Presentation Notes: Talking Points
By the end of this presentation, participants should be able to:
Identify two physiological changes associated with menopause
Identify three types of symptoms women commonly experience during perimenopause and menopause
Discuss key findings from the Women’s Health Initiative (WHI) on coronary heart disease, breast cancer, venous thromboembolic events, stroke, and osteoporotic fractures and how these findings should be applied to the treatment of menopausal women

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
By the end of this presentation participants should be able to:
Describe three effective talking points about menopausal therapy that help patients make informed decisions about hormone therapy
Discuss four basic differences between prescription hormone therapies
Discuss the current data on herbal hormone products
List four requisites for individualizing hormone therapy

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
The menopause, or the climacteric, is the cessation of menses, diagnosed retrospectively after 12 months have passed without menstruation. Perimenopause is the period that begins with the first signs and symptoms of endocrinologic change, during which the menstrual cycle becomes irregular, and ends one year after the final menstrual cycle. [1]
Menopause transition, a term sometimes used synonymously with perimenopause, also begins at the first signs and symptoms of endocrinologic change but ends with the final menstrual cycle. [1]
About 10% of women do not experience perimenopause and have regular menses until menstruation ceases abruptly. [2]

References
Utian WH. Semantics, menopause-related terminology, and the STRAW reproductive aging staging system. Menopause. 2001;8(6):398-401.
North American Menopause Society. Menopause Curriculum Study Guide. 2002. Available at: http://www.menopause.org. Accessed March 10, 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
The primary estrogen in premenopausal women is 17 beta-estradiol, which is produced mainly in the ovary from the aromatization of testosterone.
Commercial estradiol products are often referred to as containing “bio-identical” estrogen because their chemical structure is identical to the estrogen made naturally by the ovaries.
Other sites, such as muscle and adipose tissue, produce smaller amounts of estrogen through the metabolism of androgens.
After menopause, these extragonadal sites become the primary source of estrogen in the form of estrone and, to a lesser extent, estradiol.
Reduced estradiol levels result in menopause-related symptoms, such as hot flashes and vaginal dryness.
During perimenopause, estrogen production by the ovary is erratic; estradiol levels are unpredictable and can fluctuate between normal, high, and low.
For this reason, measurement of FSH and estradiol is not helpful for diagnosis during perimenopause.
Symptoms are a better marker of perimenopausal status.

Reference
Gruber CJ, Tschugguel W, Schneeberger C, Huber J. Production and actions of estrogens. N Engl J Med. 2002;346(5):340-52.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Vasomotor symptoms are caused by estrogen withdrawal, whereas genitourinary symptoms are caused by a prolonged reduction in estrogen levels.
Thus, women generally experience vasomotor symptoms in early menopause and genitourinary symptoms progressively over time after menopause.
Hot flashes are described as an intense sensation of warmth in the upper body that lasts about four minutes and ends in a cold or sweating sensation.
Of the women who develop vasomotor symptoms, most will experience symptoms for no more than two to three years, but some continue to have symptoms for several years.

References
Nevin JE, Pharr ME. Preventive care for the menopausal woman. Prim Care. 2002;29(3):583-97.
Stenchever MA, Droegemueller W, Herbst AL, Mishell DR, Jr, eds. Comprehensive Gynecology. 4th ed. St. Louis: Mosby, Inc.; 2001.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
The incidence of osteoporosis increases substantially after menopause.
Estrogen reduction leads to increased rates of bone resorption, although the rate of bone formation remains unchanged.
By age 80, 20% of white women without estrogen therapy develop hip fractures, and 15% of these women will die within six months from the fracture or its complications. [1]
The risk of atherosclerotic disease, including coronary heart disease and stroke, increases with age.
Before age 50, the gender ratio for myocardial infarction is 1:3, with men having the greater incidence of disease. [1]
After age 50, the rate of increase is greater in women than in men, so that by age 65, the ratio is 1:2, and by age 80, it is 1:1. [1]
Just as for men, cardiovascular disease is the leading cause of death of women. [2]

References
Stenchever MA, Droegemueller W, Herbst AL, Mishell DR, Jr, eds. Comprehensive Gynecology. 4th ed. St. Louis: Mosby, Inc.; 2001.
Wenger NK. Coronary heart disease: older woman’s major health risk. Brit Med J. 1997;315:1085-90.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
The release of data from two large clinical trials—the Women’s Health Initiative (WHI) and the Heart and Estrogen/progestin Replacement Study (HERS)—and the associated media attention have had an immense impact on patient and provider opinion about hormone therapy.
Many patients are confused and fearful—in some cases, panicked—by the media hype.
In the days following the release of the first data from the WHI, many women contacted their providers, and some abruptly discontinued hormone therapy and experienced a predictable return of menopause-related symptoms over the ensuing months.
Many providers are uncertain how to handle patients’ concerns and how to counsel patients responsibly about hormone therapy.
During this presentation, I will attempt to clarify the data from the WHI and HERS, describing the findings and the limitations.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
That hormone therapy is effective at relieving the vasomotor symptoms of menopause is well established.
Less clear has been whether hormone therapy imparts other health benefits, such as cardioprotection or reduced risk of osteoporotic fractures, to a degree that outweighs the risk of clinically significant adverse events.
Early studies that employed an observational design reported conflicting results: one found that HT users had half the risk of cardiovascular disease of women taking placebo; another found that HT users had twice the risk.
HERS was a randomized, blinded, placebo-controlled secondary prevention trial in which 2,763 women with established coronary artery disease (defined as myocardial infarction, coronary artery bypass grafting surgery, percutaneous coronary revascularization, or angiographic evidence of 50% or more occlusion of one or more major coronary arteries) were randomly assigned to receive either 0.625 mg of CEE with 2.5 mg of MPA or placebo.
The study found a statistically significant time trend, with more CHD events occurring in the hormone group during Year 1 of the study versus the placebo group. Fewer CHD events occurred during Years 4 and 5.

References
Coope J. Double-blind cross-over study of estrogen replacement therapy. In: Campbell S, ed. Management of the Menopause and Post-Menopausal Years. Lancaster, England: MTP Press, Ltd.;1976.
Baumgardner SB, Condrea H, Daane TA, et al. Replacement estrogen therapy for menopausal vasomotor flushes. Comparison of quinestrol and conjugated estrogens. Obstet Gynecol. 1978;51(4):445-52.
Stampfer MJ, Willett WC, Colditz GA, et al. A prospective study of postmenopausal estrogen therapy and coronary heart disease. N Engl J Med. 1985;313:1044-9.
Wilson PWF, Garrison RJ, Castelli WP. Postmenopausal estrogen use, cigarette smoking, and cardiovascular morbidity in women over 50: the Framingham Study. N Engl J Med. 1985;313:1038-43.
Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280(7):605-13.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
The WHI had a randomized, double-blind, placebo-controlled design and included two arms: an estrogen-progestogen (E-P) arm, which included about 16,600 women, and an estrogen-only arm for women without a uterus, which included about 11,000 patients.
The WHI focused on older women because the rates of the primary outcomes studied are higher at older ages and limited the number of subjects who were recently postmenopausal, because of concern about a potentially high drop-out rate among women in the placebo group who were experiencing menopausal symptoms.
The E-P arm of the WHI was terminated in July 2002 because of an increase in breast cancer, an increase in coronary events, and an unfavorable global index indicating that the overall risk exceeded the documented benefits.
The E-only arm of the WHI was terminated in March 2004 because of an increase in stroke risk among women in the active treatment group.  

References
Rossouw JE, Anderson GL, Prentice Rl, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-33.
Anderson GL. Press Conference Remarks. July 9, 2002. Available at http://www.whi.org/findings/ht/eplusp_press_anderson.php. Accessed March 6, 2007.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
A thorough understanding of the implications of the WHI results can help clinicians counsel patients about the relative risks and benefits associated with hormone therapy.
Specific data follow on the next slides.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
 Women treated with E-P had a 24% higher risk of CHD than women in the placebo group (hazard ratio 1.24). This figure was not statistically significant, however, meaning that active treatment neither promoted nor protected against CHD.
The absolute rate of CHD events was 39 cases per 10,000 person-years for the HT group and 30 cases per 10,000 person-years for the placebo group.
The investigators also observed a time trend. There was an increased risk of CHD apparent at Year 1 and a longitudinal trend toward benefit overall.
The estrogen-only arm also found no increased or decreased risk of CHD in women treated with HT (hazard ratio 0.91; 95% CI 0.72-1.15). There was a non-significant trend toward CHD benefit among women aged 50-59, suggesting that HT may be somewhat more favorable in younger than older women.
In comparison with HERS and the E-P arm of the WHI, in the estrogen-only arm, there was no increase in CHD risk in the first year of the study. Although the study had inadequate statistical power to draw definitive conclusions, there was a suggestion of differential effects by age in the estrogen-only arm with a potentially reduced rate of CHD in women 50 to 59 years old. The cumulative effect of these data suggested a possible small benefit with longer-term use.
A case-control observational study of a subgroup of women in the WHI who did not want to be randomly assigned found that the risk of CHD was lower among current HT users than non-users, with a relative risk of about 0.5 among those at the lowest tertile for baseline cardiovascular risk markers. The explanation for these findings is not entirely clear; however, these women clearly survived the early harm found in the randomized trial and thus may be at lower risk for CHD.

References
Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003;349(6):523-34.
Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA. 2004;291:1701-12.
Pradham AD, Manson JE, Rossouw JE, et al. Inflammatory biomarkers, hormone replacement therapy, and incident coronary heart disease. JAMA. 2002;288:980-7.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
 In the definitive outcome-specific paper from the WHI, there were more invasive breast cancers (unweighted hazard ratio 1.24; unweighted 95% CI 1.01-1.54; weighted P = 0.003) and more total breast cancers (unweighted hazard ratio 1.24; unweighted 95% CI 1.02-1.50; weighted P <0.001) in the E-P treated women than in the women receiving placebo.
There was no significant difference between the groups in rate of in situ breast carcinoma. In addition, the invasive breast cancers were larger and more advanced at diagnosis in the active treatment arm (P = 0.04 for both comparisons).
In the estrogen-only arm, an opposite trend was observed, with a non-significant reduction in risk of breast cancer among women treated with HT (hazard ratio 0.77; adjusted 95% CI 0.57-1.06).

References
Chlebowski RT, Hendrix SL, Langer RD, et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women’s Health Initiative Randomized Trial. JAMA. 2003;289(24):3243-53.
Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA. 2004;291:1701-12.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
The risk of VTE was increased among women in the HT group compared with the placebo group.
The hazard ratio for pulmonary embolism was 2.13 (95% CI 1.39-3.25); the absolute risk attributable to treatment with E-P was eight additional cases of PE per 10,000 person-years.
In the estrogen-only arm, the incidence of VTE (including both deep vein thrombosis and pulmonary embolism) was increased in women treated with estrogen compared with women who received placebo (28 versus 21 per 20,000 person-years), but only the rate for DVT reached statistical significance.

References
Rossouw JE, Anderson GL, Prentice Rl, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-33.
Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA. 2004;291:1701-12.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
In the E-P arm, there was an increased rate of ischemic stroke among women treated with HT compared with those who received placebo.
The hazard ratio for ischemic stroke was 1.44 (95% CI 1.09-1.90).
There was no increased risk of hemorrhagic stroke.
The increased risk was observed in all age groups and was regardless of baseline stroke risk.
There was a slight increased risk of stroke, equivalent to approximately 12 additional events per 10,000 person-years (44 versus 32 per 10,000 person-years), among treated women in the estrogen-only arm of the WHI compared with women who received placebo.

References
Wassertheil-Smoller S, Hendrix SL, Limacher M, et al. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA. 2003;289(20):2673-84.
Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA. 2004;291:1701-12.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
In the E-P arm of the WHI, the women treated with HT had a statistically significant lower risk of experiencing an osteoporotic fracture than those who received placebo (hazard ratio 0.76; 95% CI 0.69-0.83).
The women in the active-treatment group also had a decreased risk of hip fractures compared with those in the placebo group in the estrogen-only arm of the WHI (hazard ratio 0.61; 95% CI 0.33-1.11; event rate 11 versus 17, P = 0.01).

References
Cauley JA, Robbins J, Chen A, et al. Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women’s Health Initiative randomized trial. JAMA. 2003;290(13):1729-38.
Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA. 2004;291:1701-12.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
In the E-P arm of the WHI, there was a statistically significant reduction in the risk of colorectal cancer among the women treated with HT compared with those who received placebo (hazard ratio 0.76; 95% CI 0.69-0.83).
There was no overall reduction in colorectal cancer with estrogen alone, although this effect also varied by age, with women aged 50 to 59 demonstrating a markedly lower rate than older participants.

References
Chlebowski RT Wactawski-Wende J, Ritenbaugh C, et al. Estrogen plus progestin and colorectal cancer in postmenopausal women. N Engl J Med. 2004;350(10):991-1004.
Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA. 2004;291:1701-12.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Among the entire cohort, 88% of whom were asymptomatic at entry into the study, there were no significant differences between the groups in most QoL measures.
Among the 574 symptomatic women age 50 to 54, hormone therapy was associated with a significant improvement in vasomotor symptoms and an increase in QoL in the domain of sleep disturbance but not in the other QoL dimensions.
The study ended before data could be analyzed in the E-only arm.

Reference
Hays J, Ockene JK, Brunner RL, et al. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med. 2003;348(19):1839-54.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Point
The rates of invasive ovarian cancer and endometrial cancer were low in the WHI, and the rates were similar among women treated with E-P and those who received placebo.

Reference
Anderson GL, Judd HL, Kaunitz AM, et al. Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women’s Health Initiative randomized trial. JAMA. 2003;290(13):1739-48.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
In a subgroup of women from the WHI who were at least 65 years of age, there was no evidence of a protective cognitive effect with HT.
More women in the treatment group experienced a clinically significant decline in Mini Mental Status Exam scores than in the placebo group (6.7% versus 4.8%; P = 0.008).
When the data from the WHI were segmented by five-year age groups, the only active treatment group with an increased risk of dementia was the one including women who were 75 to 80 years of age.
In the estrogen-only arm of the WHI, there was a non-significant trend toward an increased risk of dementia and mild cognitive impairment in women treated with HT compared with women who received placebo.

References
Rapp SR, Espeland MA, Shumaker SA, et al. Effect of estrogen plus progestin on global cognitive function in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003;289(20):2663-72.
Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003;289(20):2651-62.
NIH asks participants in Women’s Health Initiative estrogen-alone study to stop study pills, begin follow-up phase. [press release]. Bethesda, MD: National Institutes of Health; March 2, 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
 Because only one-third of women were younger than 60 years old, only 13% were 50 to 54 years old, and only 16% were within five years of their final menstrual period, the WHI does not provide strong evidence about younger women who are closer to menopause—the women who are most likely to initiate HT for treatment of menopausal symptoms.
Evaluating the subgroup of women in the WHI who were 50 to 54 years of age is risky, because the study was not designed to provide reliable data on these women.
Investigators are following participants to gather and subsequently publish information about the events that occur after cessation of HT.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
There is some preliminary evidence that the risks and benefits of HT may be different in younger versus older women.
In a recent analysis of first-year data from two randomized clinical trials that included more than 4,000 women with a mean age of 53.6 years (average 4.9 years postmenopausal), the overall incidence rate of CHD and vascular events combined was lower in the active treatment group than in the placebo group (1.96 versus 3.01 events per 1,000 person-years). [1]
Overgeneralizing the data from the WHI may inadvertently obscure a beneficial effect in a particular subgroup of patients.
More data are clearly needed to delineate the benefits and risks of HT in younger postmenopausal women.
Individualization of treatment, including assessment of the risks and benefits for each woman, is critical, especially in light of the attention, confusion, and misinformation that now surround HT.

Reference
Lobo RA. Evaluation of cardiovascular event rates with hormone therapy in healthy, early postmenopausal women: results from 2 large clinical trials. Arch Intern Med. 2004;164(5):482-4.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Conclusions from WHI and HERS:
Women who are relatively older and many years postmenopausal should not take oral HT for cardio protection
Oral HT should not be used to treat cardiovascular disease
Because the WHI and HERS studied only oral HT, no firm conclusions can be drawn about HT administered by other routes.
Because these studies evaluated mostly older postmenopausal, firm conclusions cannot be drawn about HT that is initiated during perimenopause.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
In response to the discontinuation of the E-P arm of the WHI in 2002, professional societies and governmental agencies released opinion statements or revised practice guidelines for HT.
American College of Obstetricians and Gynecologists Guidelines:
Women using HT for prevention of cardiac disease or osteoporosis should discontinue use.
HT may be appropriate to treat menopause-related symptoms, depending on an individual woman’s risks and benefits.
If HT is used for menopause-related symptoms, it should be used for the shortest possible duration in the smallest effective dose.
The most recent ACOG guidelines were released in 2004.

Reference
American College of Obstetricians and Gynecologists. Hormone Therapy: Executive Summary. Obstet Gynecol; 2004 Oct; 104(4 Suppl):1S-4S.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
North American Menopause Society Guidelines     
If HT is prescribed solely for symptoms of vaginal and vulvar atrophy, local therapy should generally be used.
HT should not be used for primary or secondary prevention of CHD or stroke.
In women at high risk for osteoporosis, for whom preventing this condition is the sole reason for use of HT, alternatives to HT should be considered.
Use of HT should be limited to the shortest possible duration, taking into account treatment goals, individual risks and benefits, and symptoms that affect quality of life.
Under strict clinical supervision and after patients are fully informed of the risks, extended use of HT is acceptable for:
Women who believe relief of their menopause-related symptoms outweighs the risks of use.
Women with moderate to severe menopause-related symptoms who are at high risk for osteoporosis.
Women at high risk for osteoporosis for whom alternative therapies are not appropriate.

Reference
North American Menopause Society. Estrogen and progestogen use in peri- and postmenopausal women: September 2003 position statement of The North American Menopause Society. Menopause. 2003;10:497-506.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Nurse Practitioners in Women’s Health Guidelines
The best candidate for HT is the woman whose quality of life is affected by menopause-related symptoms.
If HT is prescribed, the lowest dose for the shortest duration should be used; patient preference about type of delivery system should guide prescription.
If urogenital concerns are the primary problem, local hormone therapy or the vaginal ring should be considered.
If HT is prescribed for menopause-related symptoms, a woman’s choice about duration of use should be respected.

Reference
Nurse Practitioners in Women’s Health. Individualized care for menopausal women: counseling women about hormonal therapy (HT). Available at: www.npwh.org/Menopausal-Women/. Accessed March 18, 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
The Food and Drug Administration guidelines
HT products are effective in treating moderate to severe vasomotor symptoms and moderate to severe vaginal dryness and for preventing osteoporosis associated with menopause.
If HT is prescribed solely for vaginal dryness, topical hormone therapies should be considered instead.
If HT is prescribed solely for prevention of osteoporosis, other treatments should be considered first, and the severity of risk should be significant.
If HT is prescribed, it should be used at the lowest effective dose and the shortest possible duration to reach treatment goals.

Reference
Food and Drug Administration. FDA updates hormone therapy information for post menopausal women. February 10, 2004. Available at: http://www.fda.gov/bbs/topcis/NEWS/2004/NEW01022.html. Accessed March 10, 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
More research on the benefits and risks associated with hormone therapy is clearly needed.
In the interim period, women need accurate information about what is currently known about HT and are looking for guidance from their health care providers about this subject.
Patients often want more than just information about HT, they want advice from their providers to help them make an informed choice.
With this in mind, it is important for providers not to allow the risks delineated for a particular population to prevent them from recommending HT to women who do not appear to be at increased risk and who may benefit from its therapeutic effects.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Point
Women with absolute contraindications to estrogen should not be prescribed systemic HT.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Initial factors to take into account include the woman’s age, time since final menstrual period, and desire to use HT.
Providers should listen and validate women’s fears, then correct any misinformation and provide accurate data.
When providing data, it is important to give patients credit for their ability to understand properly explained scientific information.
Healthy dietary choices, regular exercise, and stress management can reduce women’s risks of chronic degenerative diseases and may be helpful in reducing symptoms associated with menopause.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
It is important for providers to put the risks delineated in the WHI in perspective.  
When counseling patients, it is important to help them understand not only the relative risk but also the absolute risk.
For example, the WHI reported a 26% increase in breast cancer, which some patients may mistakenly believe means that they individually have a 26% chance of developing breast cancer if they use this treatment.
Instead, the 26% reflects the difference in absolute breast cancer rates between the placebo and E-P treated groups (3.0 and 3.8 per 1,000 women per years, respectively). The increased risk translates into a rate of 0.8 per 1,000 women-years, or less than one additional breast cancer case per 1,000 women per year. [1]

References
International Food Information Council. Worth the risk: putting activities in perspective. November/December 1999. Available at: http://www.ific.org/foodinsight/1999/nd/worthriskfi699.cfm. Accessed March 25, 2004.
Nurse Practitioners in Women’s Health. Individualized care for menopausal women: counseling women about hormonal therapy (HT). Available at: www.npwh.org/Menopausal-Women/. Accessed March 18, 2004.
Rossouw JE, Anderson GL, Prentice Rl, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321-33.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Point
If 10,000 women were treated with HT, over the course of one year, this number of additional (or fewer) women in the treatment group would develop the outcome compared with the placebo group.

Reference
Women’s Health Initiative. June 2002 HRT Update. Available at: http://www.whi.org/updates/update_hrt2002.asp. Accessed March 25, 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Many women fear that they will develop breast cancer, and it may be especially helpful to put the risk of breast cancer associated with HT in perspective.
Risk per 1,000 women aged 50 to 70
Body mass index (BMI) more than 31 kg/m2 compared with less than 20 kg/m2

References
Huang Z, Hankinson SE, Colditz GA, et al. Dual effects of weight and weight gain on breast cancer risk. JAMA. 1997;278(17):1407-11.
LaCroix AZ, Burke W. Breast cancer and hormone replacement therapy. Commentary. Lancet. 1997;350:1042-3.
Longnecker MP, Paganini-Hill A, Ross RK. Lifetime alcohol consumption and breast cancer risk among postmenopausal women in Los Angeles. Cancer Epidemiol Biomarkers Prev. 1995;4(7):721-5.
Smith-Warner SA, Spiegelman D, Yaun SS, et al. Alcohol and breast cancer in women: a pooled analysis of cohort studies. JAMA. 1998;279(7):535-40.
Thune I, Tormod B, Lund E, Gaard M. Physical activity and the risk of breast cancer. N Engl J Med. 1997;336:1269-75.
Women’s Health Initiative. June 2002 HRT Update. Available at: http://www.whi.org/updates/update_hrt2002.asp. Accessed March 25, 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
This slide helps put a patient’s relative risk of breast cancer into perspective.

Reference
Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Lancet. 1997;350(9084):1047-59.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
When a woman’s goal is disease prevention, a lower risk of adverse events is essential. When the goal is treatment of moderate to severe symptoms, a higher risk may be tolerable.
Clarifying her goals for treatment will help a woman understand the potential benefits to her and make an informed decision about whether or not to use HT.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Point
If there is one aspect of menopausal care that the results of the WHI have highlighted, it is the fact that hormone therapy must be individualized to best suit a woman’s personal goals, needs, and risk factors.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Several estrogen products are touted as being the most “natural” for menopause-related symptoms:
17-beta estradiol because it is the estrogen made in abundance before menopause
estrone because it is the estrogen most abundant after menopause
CEE because it is manufactured from a natural source—horse urine
However, 17-beta estradiol given orally is metabolized by the liver to estrone, so the distinction from estrone products is moot once the product has been taken by mouth.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
In women with an intact uterus, the addition of progestogen to estrogen is necessary to prevent endometrial hyperplasia and carcinoma.
The relative risk of endometrial cancer after 10 years of unopposed estrogen therapy is 8.0.
Micronized progesterone is used orally to improve absorption.
Micronized progesterone does not interfere with lipid benefits associated with oral estrogen, whereas the synthetic progestogens block a large proportion of the estrogen-related benefit.

References
Adams MR, Kaplan JR, Manuck SB, et al. Inhibition of coronary artery atherosclerosis by 17-beta estradiol in ovariectomized monkeys. Lack of an effect of added progesterone. Arteriosclerosis. 1990;10(6):1051-7.
Adams MR, Register TC, Golden DL, Wagner JD, Williams JK. Medroxyprogesterone acetate antagonizes inhibitory effects of conjugated equine estrogens on coronary artery atherosclerosis. Arterioscler Thromb Vasc Biol. 1997;17(1):217-21.
Espeland MA, Stefanick ML, Kritz-Silverstein D. Effect of postmenopausal hormone therapy on body weight and waist and hip girths. Postmenopausal Estrogen-Progestin Interventions Study Investigators. J Clin Endocrinol Metab. 1997;82(5):1549-56.
North American Menopause Society. Menopause Curriculum Study Guide. 2002. Available at: http://www.menopause.org. Accessed March 10, 2004.
Williams JK, Honore EK, Washburn SA, Clarkson TB. Effects of hormone replacement therapy on reactivity of atherosclerotic coronary arteries in cynomolgus monkeys. J Am Coll Cardiol. 1994;24(7):1757-61.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Types of progestogens:
Synthetic progestogens
Structurally related to progesterone
MPA
Structurally related to testosterone
norethindrone
norethindrone acetate
norgestrel
levonorgestrel
The most important clinical distinction between the progestogens is their relative potency, or the degree to which they downregulate the estrogen receptors in the endometrium and elsewhere in the body.
MPA is the most potent progestogen available, strongly downregulating estrogen receptors in the uterus but also leading to more frequent adverse effects, such as breast tenderness and swelling, than other progestogens.
Progesterone (given in micronized form to enhance gastrointestinal absorption) is about 50 times less potent than MPA, based on analysis of endometrial changes in estrogen-primed postmenopausal women; levonorgestrel and norethinedrone are more potent than MPA.
Nevertheless, micronized progesterone is as effective as MPA in protecting against estrogen-induced endometrial hyperplasia.
Both the WHI and HERS used oral estrogen (0.625 mg of CEE) with continuous progestogen (2.5 mg of MPA).
These studies used the progestogen with the strongest potency—a distinction that may be important in applying the study results to populations that use other, less-potent, progestogens.
 
References
North American Menopause Society. Role of progestogen in hormone therapy for postmenopausal women. Menopause. 2003;10:113-132.
King RJ, Whitehead MI. Assessment of the potency of orally administered progestins in women. Fertil Steril. 1986;46:1062-6.
PEPI Investigators. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1995; 273:199-208.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Because of its glucocorticoid-like activity, swelling and breast pain may be more common with MPA than other progestogens.
Androgen-related effects, such as acne and hirsutism, are more common with levonorgestrel and norethinedrone.
High-dose progesterone is associated with dizziness and fatigue, but these symptoms are generally mild at recommended doses.
Progestogens vary in their metabolic effects.
For example, MPA blunts most of the increase in HDL cholesterol seen with concomitant oral estrogen use and does little to prevent the increase in triglycerides seen with oral estrogen. In contrast, norethinedrone acetate decreases HDL cholesterol levels and reduces the elevated triglyceride levels associated with oral estrogen intake. Micronized progesterone has an essentially neutral effect on lipids, preserving estrogen effects including the rise in HDL cholesterol, decrease in LDL cholesterol, and increase in triglycerides.

References
North American Menopause Society. Role of progestogen in hormone therapy for postmenopausal women. Menopause. 2003;10:113-32.
Mitchell JL, Walsh J, Wang-Cheng R, Hardman JL. Postmenopausal hormone therapy: a concise guide to therapeutic uses, formulations, risks, and alternatives. Prim Care. 2003;30(4):671-96.
PEPI Investigators. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1995; 273:199-208.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Products administered via the vagina include those that are used for their local effects only (creams, vaginal tablets, and the Estring vaginal ring) and one that is used for both local and systemic effects (the Femring vaginal ring).
Oral estrogen undergoes first-pass metabolism in the liver and thus requires a higher dose to achieve the same bioavailability as other routes of administration.

Reference
Slater CC, Hodis HN, Mack WJ, et al. Markedly elevated levels of estrone sulfate after long-term oral, but not transdermal, administration of estradiol in postmenopausal women. Menopause. 2001;8(3):200-3.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Administration via the oral, transdermal, and systemic vaginal (e.g., Femring) routes consistently lead to systemic effects, but local vaginal administration at routine doses generally does not.
Transdermal HT provides more consistent and even blood hormone levels, which translates into prevention of withdrawal symptoms. In addition to effectiveness at lower doses compared with oral administration, products administered in low doses by the non-oral route avoid first-pass hepatic effects.
Oral estrogen is associated with prothrombotic changes in hemostatic effects and an increase in inflammatory markers, such as C-reactive protein, that are seen only minimally with transdermal HT.
The risk of VTE is much greater with oral than with transdermal estrogen—the ESTHER Study documented a 3.5-fold greater risk in women using oral estrogen compared with the placebo group and no significant difference in VTE rate between the transdermal group and the placebo group.
Vaginal systemic therapy with Femring was not associated with an increased risk of VTE in the clinical studies supporting its FDA approval.
Oral estrogen can improve lipid values, such as LDL cholesterol, more than transdermal HT. Limited data are available comparing oral estrogen to vaginal creams, gels, or rings.  
Progestogen is not needed for local vaginal therapy, but it is needed for systemic vaginal therapy, including with Femring.
The choice of route should depend on the woman’s preference, bearing in mind the need to support adherence, and the particular clinical scenario.

References
Vongpatanasin W, Tuncel M, Wang Z, et al. Differential effects of oral versus transdermal estrogen replacement therapy on C-reactive protein in postmenopausal women. J Am Coll Cardiol. 2003;41(8):1358-63.
Decensi A, Omodei U, Robertson C, et al. Effect of transdermal estradiol and oral conjugated estrogen on C-reactive protein in retinoid-placebo trial in healthy women. Circulation. 2002;106(10):1224-8.
Scarabin PY, Oger E, Plu-Bureau G, for the Estrogen and ThromboEmbolism Risk (ESTHER) Study Group. Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet. 2003;362(9382):428-32.
Femring [package insert]. Rockaway, NJ: Warner Chilcott; March 2003.
Hemelaar M, van der Mooren MJ, Mijatovic V, et al. Oral, more than transdermal, estrogen therapy improves lipids and lipoprotein(a) in postmenopausal women: a randomized, placebo-controlled study. Menopause. 2003;10(6):550-8.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Some pharmacies offer custom-made combination HT, a “special for me” therapy.
There is no evidence that minute alterations in the concentration of hormones administered correlate with better therapeutic outcomes.
There is no evidence supporting “level-shooting” or frequent dosage adjustment, based on regular serum testing, as a valid method for HT management.
The endpoints for HT therapy should be based on the woman’s symptoms, goals, and risk/benefit profile, not blood hormone levels.
The popularity of compounding pharmacies highlights women’s preference for individualized therapy.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Progestogens can be administered in a variety of regimens for endometrial protection.
The old cyclic regimen has fallen out of use, because many women experience menopause-related symptoms on a monthly basis with this regimen.
The long-cycle regimen must be used with caution, because few data are available about its safety and efficacy.
If the long-cycle regimen is chosen, a potent progestogen should be used to ensure sufficient endometrial shedding, and the frequency of progestogen dosing should be based on the type of progestogen used and the bleeding response.
The cyclic combined regimen may be helpful, after appropriate evaluation of the endometrium, for women who experience bleeding on the continuous combined regimen.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
SCE = synthetic conjugated estrogens
Est. E = esterified estrogens
CEE = conjugated equine estrogens

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
MPA = medroxyprogesterone acetate
NETA = norethinedrone acetate
EE = ethinyl estradiol
CEE = conjugated equine estrogens
Ortho-Prefest uses a pulsed regimen for norgestimate: 3 days off then three days on, and repeated

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Includes patches and gel
NETA = norethinedrone acetate
EE = ethinyl estradiol

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Premarin and Estrace are creams. [check to see if premarin is a cream]
Vagifem is a tablet.
Crinone and Prochieve are gels.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care in March 2005. Original funding received from Solvay Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by Barb Malat, CNP, PA-C, Sarah B. Freeman, PhD, ARNP, FAANP, and Catherine Juve, PhD, MSPH, MN, CNP, RN, in January 2007.

Presentation Notes: Talking Points
Estring and Femring are vaginal rings.
Mirena is an intrauterine system (IUS).
Estring is for local use only.
Femring is for local and systemic use. It is available in two dosages—0.05 mg/day and 0.10 mg/day—and does require the addition of a progestogen in women with an intact uterus. [1]

Reference
Femring [package insert]. Rockaway, NJ: Warner Chilcott; March 2003.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Herbal products, including botanical and dietary supplements, are not controlled or screened by the FDA.
Despite this, studies show that many women in the US use (or have used) some herbal products to control menopause-related symptoms, either alone or in combination with prescription drugs.
Patients may not tell their providers if they are using any herbal products because of the perception that they are “natural.”
Providers should be aware of the most common herbal products used for menopause-related symptoms, and should ask patients at every visit if they are using any.

Reference
Carroll DG. Nonhormonal Therapies for Hot Flashes in Menopause. Am Fam Physician. 2006 Feb 1;73(3):457-64
Ma J, Drieling R, Stafford RS. US women desire greater professional guidance on hormone and alternative therapies for menopause symptom management. Menopause; 2006 May-Jun; 13(3):506-16.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Studies have yielded conflicting evidence about the effectiveness of herbal products in controlling menopause-related symptoms.
The most popular herbal products used for menopause are black cohosh, red clover, dong quai, soy, and evening primrose seed oil.
Studies have found that soy protein and black cohosh may be helpful for improving vasomotor symptoms, particularly hot flashes, for some women.
Studies of the effects of other herbal products on menopause-related symptoms have been inconclusive. More rigorous studies are needed in this area.

References
Carroll DG. Nonhormonal Therapies for Hot Flashes in Menopause. Am Fam Physician. 2006 Feb 1;73(3):457-64.
Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19; 118(Suppl 12 B):98-108.
National Institutes of Health (NIH) National Center for Complimentary and Alternative Medicine (NCAM). Backgrounder: Do CAM Therapies Help Menopausal Symptoms? NCCAM Publication No. D297. November 2005. Available at http://nccam.nih.gov/health/menopauseandcam/. Accessed April 9, 2007.
Newton KM, Reed SD, LaCroix AZ, et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med; 2006 Dec 19; 145(2):869-79.
Pockaj BA, Gallagher JG, Loprinzi CL, et al. Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol; 2006 Jun 20; 24(28):2836-41.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Testosterone is naturally converted to estrogen; this conversion is especially important in postmenopausal women, because their ovarian synthesis of estrogen is greatly reduced.
Estratest® and Estratest® HS are combinations of esterified estrogens and methyltestosterone.
The availability of Estratest and Estratest HS is under consideration by the FDA, which is re-evaluating the net benefits of estrogen/androgen products.
Testosterone has been administered to postmenopausal women to improve sexual function, although it is not approved by the FDA for this use.
For more information on the use of androgens, refer participants to the ARHP monograph, Perimenopause Update: Women and Libido—Is There a Role for Testosterone? Available at: http://www.arhp.org.

References
OBGYN.net. FDA revises findings on estrogen/androgen combinations products. May 8, 2003. Available at: http://www.obgyn.net/newsheadlines/womens_health-Hot_Flashes-20030508-31.asp. Accessed March 24, 2004.
Estratest and Estratest HS [package insert]. Marietta, GA: Solvay Pharmaceuticals, Inc.; 2004.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Raloxifene (Evista®) is FDA approved for the treatment and prevention of osteoporosis in postmenopausal women.
It appears to lack estrogen-like effects on the uterus and breast tissue, but it can cause hot flashes as a result of estrogen receptor blockade.

Reference
Evista [package insert]. Indianapolis, IN: Eli Lilly and Company; March 2001.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Women want care that is personalized for them.
In general, they do not want to receive rote management of their menopause-related symptoms, and the results of the WHI support the validity of not using a “one size fits all” approach.
Individualize care requires
Gathering information—such as:
patient’s age, the date of last menstrual period, medical history, family history, lifestyle factors, lipid profile, and nutritional status
current or past therapies used for menopause-related symptoms
what she knows or has heard about HT and about any fears or concerns she may have about it
physical examination with laboratory testing as needed
Providing information—help each woman obtain accurate information about the risks and benefits specific to her situation.
Supporting informed decision making—help women understand the difference between absolute and relative risk, thus allowing them to place the risks and benefits of HT in perspective.
Addressing ongoing health needs—reassess (at least annually) the continued need for HT and ensure that women are receiving comprehensive preventive care.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
In deciding between oral or non-oral HT, consider
Mary’s preference about the route of administration
medical history
other factors
if she has a low HDL cholesterol level, oral HT might be a good choice
if she has hypertriglyceridemia, oral HT would not be as good a choice
if she has low libido, transdermal HT or estrogen combined with an androgen might be a good choice, to avoid increasing production of sex hormone-binding globulin (SHBG) and the resultant reduction in bioavailable estrogen and testosterone (more on SHBG in Case 6)
It may be helpful to remind Mary that HT could be used for a relatively short time to address her vasomotor symptoms and then gradually reduced over time to avoid estrogen withdrawal symptoms.
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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Zelda also may be a candidate for systemic HT use to manage any systemic symptoms, if appropriate.
However, to avoid increased risk of VTE, non-oral systemic therapy would be a better option than oral therapy.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
If Ann’s sexual dysfunction had been related solely to vaginal dryness, a lubricant might be effective.
For more information on the use of androgens, refer participants to the ARHP monograph, Perimenopause Update: Women and Libido—Is There a Role for Testosterone? Available at: http://www.arhp.org.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
HT should not be used during perimenopause, because the addition of estrogen will exacerbate symptoms during the periods of higher estradiol production.
If education and lifestyle changes are not successful, the “gold standard” for treatment of symptoms during perimenopause is a low-dose oral contraceptive to even out irregular estrogen levels—but Terri has an absolute contraindication to OCs.
There are as yet no data about the safety of the contraceptive patch or contraceptive ring among women with a history of VTE.
To use the patch for augmentation, she would remove the patch during periods of higher ovarian estradiol production, when she experienced breast tenderness, for example.
If she were having heavy bleeding, estrogen augmentation would not be advisable; the levonorgestrel intrauterine system could be considered instead. 
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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Data from the estrogen-only arm of the WHI should generally be applied with caution to Katherine’s situation because of her relatively young age. However, the WHI estrogen-alone study found no increased risk of breast cancer overall, with lower risk estimates for women 50 to 59 and 60 to 69 compared with those 70 to 79.
In discussing the fear of breast cancer from estrogen, it may be helpful to differentiate between factors that promote breast cancer and those that initiate it; estrogen may stimulate the growth of cancerous cells that are already present rather than stimulate the transformation into cancerous cells.
Note that NPWH recommendations state, “If HT is prescribed for menopause-related symptoms, a woman’s choice about duration of use should be respected.”

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Oral estrogen can increase sex hormone-binding globulin (SHBG).
This lowers bioavailable testosterone and can lower bioavailable estrogen, thus triggering estrogen-withdrawal or estrogen-deficiency symptoms.
Increasing the dose of the oral estrogen will only exacerbate the situation.
Androgens reduce SHBG.
Questioning about symptom frequency and pattern can alert providers to this common and important phenomenon.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points
Many questions remain unanswered about hormone therapy.
Further study, in the form of well-designed, controlled trials, is needed to assess the potential risks and benefits of hormone therapy in these areas.

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

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Original content for this slide submitted by the ARHP Clinical Advisory Committee for Hormone Therapy and Menopause Care

Presentation Notes: Talking Points, At the conclusion of a lecture based on this curriculum, participants should be able to:, Understand why assessment of sexual function should be included in the health care of middle-aged and older adults. Incorporate assessment of sexual function and risk for STIs into routine health care of mature adults. Identify factors that may affect sexual function in older men and women. Provide appropriate treatment, counseling, or referral to patients experiencing problems with sexuality.

Presentation Notes: ,

Presentation Notes: Talking Points, Myths and stereotypes have surrounded the elderly in the past. For centuries, Western cultural beliefs held that sexuality among the elderly was immoral, inappropriate and perverse. Similar attitudes, or at least a certain ambivalence about the acceptability of sexual expression after a certain age, persist even today among many people, although the numbers sharing these attitudes may be declining. Such attitudes clearly do not reflect current sexual behavior patterns among older, “mature” Americans.

Presentation Notes: Talking Points, Discussion of sexuality has become increasingly open in recent decades. The amount of information available on these issues has increased as well. Masters and Johnson in the 1960s documented stages in the human sexual response of both men and women, and detailed the anatomical and physiologic changes associated with each of those stages. , Beginning with the Kinsey Report, a series of studies have attempted to describe the sexual activity patterns among older adults. Such efforts are complicated by privacy and comfort issues surrounding the discussion of sexuality. All surveys, by either written questionnaire or telephone interview, are limited by a number of factors:, Many people will not respond;, Some who do respond may not fully understand the questions asked;, The truthfulness of responses provided cannot be assessed;, Older Americans may be less comfortable discussing sexuality than younger Americans, and some cultural norms prohibit these discussions at all;, Cultural taboos against homosexual behaviors may make same-sex relationships underrepresented and, indeed, the surveys reviewed here did not ask about same-sex activities or relationships. Despite these limitations, a number of surveys have tried to assess the sexual norms of older Americans. Each survey has its strengths and weaknesses with respect to demographic research, but generally the results find similar trends. Older Americans, in general, lead an active and satisfying sexual life into their 60s, with a decline in the 70s.

Presentation Notes: Talking Points, While much of the news about sex after 50—or 60—is encouraging, it is also important to keep in mind that these age groups are also characterized by a rise in the number of people who are widowed—especially women.

Presentation Notes: Talking Points, As these figures from the 2000 Census make clear, approximately 15% of people in their 50s are divorced, and there’s little reason to think that percentage will decline as this cohort moves into their 60s and 70s. By the age of 75, more than 45% of people are widowed, although the figure for men in this age group is 22.7% and for women it is 60.5%. Age Widowed Divorced, 50-54 3.1% 15.4%, 55-59 5.7% 15.3%, 60-64 9.8% 12.2%, 65-69 16.7% 9.6%, 70-74 25.6% 7.5%, 75+ 45.6% 4.5%,

Presentation Notes: Talking Points, The Duke Longitudinal Study, begun in 1969, studied sexual function in a sample of 261 white men and 241 white women between the ages of 46 and 71. Participants were randomly selected from the lists of a local insurance plan, and tended to be of middle to upper socioeconomic status. Among those surveyed who indicated they had stopped having sexual relations, there were striking differences in reasons given by men and women. Only 10% of women reported cessation of activity due to their own illness, loss of interest, or inability to perform sexually. This explanation for lack of sexual activity among women in this early study is borne out by later surveys.

Presentation Notes: Talking Points, One of the first questionnaires to assess sexual behavior in a large number of older Americans was the Consumers Union survey of 1977. This self-selected group of 1844 women and 2402 men responded to a request published in Consumer Reports magazine that was specifically targeted to people born before 1928 (people 50 and older at that time). Readers of Consumer Reports do not represent a random sample of Americans, and are of higher than average income and education. Also, readers who were uncomfortable responding to the questions or who were not sexually active will be underrepresented. The Consumer Reports survey found that the level of interest, ease of arousal, and importance of the sexual part of their relationship declined with age. Married respondents of both sexes reported a greater interest in sex.

Presentation Notes: Talking Points, One of the first questionnaires to assess sexual behavior in a large number of older Americans was the Consumers Union survey of 1977. This self-selected group of 1844 women and 2402 men responded to a request published in Consumer Reports magazine that was specifically targeted to people born before 1928 (people 50 and older at that time). Readers of Consumer Reports do not represent a random sample of Americans, and are of higher than average income and education. Also, readers who were uncomfortable responding to the questions or who were not sexually active will be underrepresented. The Consumer Reports survey found that the level of interest, ease of arousal, and importance of the sexual part of their relationship declined with age. Married respondents of both sexes reported a greater interest in sex.

Presentation Notes: Talking Points, In 1998, the National Council on Aging (NCOA) surveyed 1292 Americans 60 years old or older. A nationally representative, randomly selected sample of Americans received a mailed questionnaire. Data were weighted for sex, age, marital status, race, and household income to reflect the proportions among the general US population. Given the relatively small sample size, using weighted analyses of even smaller sub-samples led the NCOA to suggest that “due to the small base size, data should be viewed as suggestive rather than as statistically projectable.”, Still, the data suggest that older Americans are sexually active in their 60s and 70s. Seniors with partners are sexually active (defined as sex at least once a month in the past year) into their 80s. Number of respondents in each age group:, 60s: Men = 254; Women = 355, 70s: Men = 213; Women = 291, 80s: Men = 54; Women = 64

Presentation Notes: Talking Points, Number of respondents in each age group:, 60s: Men = 200; Women = 215, 70s: Men = 115; Women = 89, 80s: Men = 20; Women = 19,

Presentation Notes: Talking Points, The American Association of Retired Persons (AARP) performed a survey in 1999. Survey was sent to 1709 men and women 45 and older and attempted to be representative of the general population. Data were weighted to reflect age and gender of the general population, but the weighted data may not be representative across the spectrum of race, culture, and income. Libido was assessed with questions regarding sexual thoughts. The presence of sexual thoughts in men and women declined with age. The absence of a sexual partner was reflected in a significantly lower incidence of sexual thoughts, particularly in women.

Presentation Notes: Talking Points, AARP asked those surveyed to indicate how often they had sexual thoughts, providing a range of response choices—from “more than once a day” to “not at all.”, The survey report prepared by NFO Research, Inc. presents responses to each choice as percentages of the total number surveyed, but does not provide the number of responses to each choice. The total number for all responses by age group and sex are as follows:, 45-59: Men = 341; Women = 368, 60-74: Men = 205; Women = 253, 75+: Men = 90; Women = 119,

Presentation Notes: Talking Points, MEN: 45-59 (N=341): 54.8%; 60-74 (N=205): 30.9%; 75+ (N=90): 19.1%, WOMEN: 45-59 (N=368): 49.6%; 60-74 (N=253): 24.2%; 75+ (N=119): 6.6%, As with other statistics presented here, the absence of a partner (particularly among older women) must be factored into our understanding of what these figures represent.

Presentation Notes: Talking Points, In 1999, ARHP initiated a telephone survey, which was conducted via OmniTel, a weekly national telephone service using a random digit dialing technique. The weighted total of those 50 years and older was 355. Findings:, Although older men and women may have less frequent sexual activity than younger age groups, they are not necessarily less content or “satisfied”, Satisfaction may reflect contentment with the nature of the sexual relationship, or contentment with the lack of one,

Presentation Notes: Talking Points, Response population:, Age 50-59, N=60, Age 60-69, N=40, Age 70+, N=34, The number represented as being sexually satisfied includes those who indicated they were either “very satisfied” or “somewhat satisfied” with their sex life. The percent of men who were “dissatisfied” increased with age.

Presentation Notes: Talking Points, Response population:, Age 50-59, N=92, Age 60-69, N=71, Age 70+, N=56, The number represented as being sexually satisfied includes those who indicated they were either “very satisfied” or “somewhat satisfied” with their sex life. As women aged, their satisfaction with their sexual lives increased. (In some cases this may have meant they were happy not being sexually active.),

Presentation Notes: Talking Points, In 2003, the American Association of Retired Persons (AARP) conducted another survey, this one online, to determine dating behavior, sexual activity, and feelings about being single among age 40+ singles. The margin of sampling error for this sample size is +2.4 percentage points at the 95% confidence level. The survey was conducted with 3500 single people ages 40-69 years old, The margin of sampling error for this sample size is +2.4 percentage points at the 95% confidence level. One of the major findings was that people in their 50s are more likely to rate sexual compatibility as a critical factor in choosing a partner. The Census Bureau reports that there are more Americans living alone than ever before: In 2002, there were about 34.4 million singles or unmarried persons age 40-69. The greater number of single persons in their 50s and above is related to the high rate of divorce in our country: 15.4% are divorced, 6.2% have never been married, and 4.4% are widowed. Survey results indicate that people in their 50s are more likely to rate sexual compatibility as a critical factor in choosing a partner.

Presentation Notes: Talking Points, In the AARP survey, 39% of single men and 61% of single women in their 50s had not had sex in the past six months. 59% of single men and 35% of single women ages 40-69 said they weren’t having sex often enough. Overall, 54% of single men and women ages 40-69 surveyed had engaged in hugging and kissing behaviors, 37% in sexual intercourse, and 39% in self-stimulation at least once in the past month.

Presentation Notes: Talking Points, Many singles in their 50s are having sex with more than one partner, according to the AARP survey, putting them at risk for STIs.

Presentation Notes: Talking Points:, The AARP also performed an online divorce survey in 2003, which included some questions about sexuality. They surveyed 581 men and 566 women between 40 and 79, who had divorced between the ages of 40 and 70. 1 in 4 men in their 50s and 1 in 3 men in their 60s viewed sex with a new partner as a way to cope with divorce. Women used exercise and a retreat into work as coping strategies. People 40 and older who divorced felt that it was a more emotionally devastating experience than losing a job, about equal to experiencing a major illness, and nearly as devastating as the death of a spouse.

Presentation Notes: Talking Points, This chart looks at remarried respondents after a midlife divorce who are having sex at least once a week,

Presentation Notes: Talking Points, Open communication between health care provider and patient is essential to identifying and addressing sexual problems effectively. Yet surveys suggest that such communication is the exception rather than the rule. A poll of U.S. adults 25 years of age or older found most were “very” or “somewhat” concerned that their physician would provide no treatment for sexual problems they reported, would dismiss their problem as psychosomatic, and/or would be uncomfortable discussing such,

Presentation Notes: The health care provider should be emotionally mature and educationally prepared to communicate with patients and couples on issues of sexuality.

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Presentation Notes: Women >40 have the second highest proportion of unintended pregnancies, so the need for effective contraception continues until menopause. No contraceptive method is contraindicated merely by age.

Presentation Notes: Controversy surrounds current attempts to medicalize sexual problems and establish “normative data” for a range of physiological measurements of female sexual response. Female sexual dysfunction is highly complex, and extends beyond physical issues; the interface between psychological processes and physiological response is not well understood. The role of drug companies in the construction of new conditions, disorders, and diseases needs more public scrutiny because there is difficulty in predicting when pharmacological treatment will be helpful.

Presentation Notes: Sexual desire is “the sum of the forces that lean us toward and away from sexual behavior.”, Levine conceptualizes sexual desire as consisting of drive (biological), motive (individual and relationship psychology), and wish (cultural) components, with four main variables—age, gender, social situation, and health—affecting desire.

Presentation Notes: If a problem related to lack of sexual desire is identified during the initial patient history-taking, then additional information must be obtained to determine the etiology of the problem and appropriate treatment. Questions to ask/examine:, What is the nature of the patient’s current sexual activity?, Has there been an identifiable event associated with loss of desire?, How much disparity is there between the patient’s desire and her partner’s?

Presentation Notes: Questions to ask/examine:, Is the disparity, if any, within statistical norms? (What is normal, anyway?), Is the problem lack of interest or fear of rejection?, Is the loss selective?, Is there interest in another sex object?

Presentation Notes: Assess past levels of desire, including autoerotic behavior or fantasies. Sexual aloofness can be used at times as a form of punishment or control. Questions to ask/examine:, Has the patient had desire in the past?, Is there an underlying effort to be sexually aloof?, Is there an issue of sexual boredom?, Has there been a prior effort to solve the problem?

Presentation Notes: The most common causes of dyspareunia among middle-aged and older women are:, Atrophic vaginitis, Non-neoplastic epithelial disorders, Vulvar vestibulitis, Decrease in vaginal caliber with decreased estrogen and rare sexual activity, Normal response following long period without sexual intercourse, The most common causes of sexual pain disorder among middle-aged and older women is atrophic vaginitis. An estimated 10 to 40 percent of postmenopausal women have symptoms of atrophic vaginitis or urogenital atrophy. Unfortunately, it is also estimated that only 20 to 25 percent of symptomatic women seek medical attention. Non-neoplastic epithelial disorders: Formerly referred to as vulvar dystrophies, these skin disorders, in which the vulvar skin is thickened, can produce chronic pain syndromes. Examples are Lichen sclerosis, Lichen planus. In the post-Viagra era, dyspareunia may be a normal response in a woman whose male partner is successfully treated for erectile dysfunction after a long period without intercourse.

Presentation Notes: Psychological treatment can and does impact sexual physiology, and a need exists to continue to develop and test psychological approaches for female sexual dysfunction, according to Heiman. In addition, prescription of a physiologic treatment that ignores the fact that human sexuality is infused with individual meaning may invite further interference with sexual functioning. Leiblum suggests that a comprehensive evaluation of a woman and her partner, prior to formalizing a treatment plan, is needed. Education and information about female sexuality, communication training, non-demand pleasuring, and permission to engage in self-pleasuring are common interventions.

Presentation Notes: Open communication between health care provider and patient is essential to identifying and addressing sexual problems effectively. Yet surveys suggest that such communication is the exception rather than the rule. A poll of U.S. adults 25 years of age or older found most were “very” or “somewhat” concerned that their physician would provide no treatment for sexual problems they reported, would dismiss their problem as psychosomatic, and/or would be uncomfortable discussing such problems. Another poll found that although 40% of women survey online did not seek help from a physician for sexual function complaints, 54% reported that they would like to talk to a clinician.

Presentation Notes: The interdisciplinary, international group felt that given that a woman’s sexuality is contextual, the relationship and the environment in which the sexual exchange occurs must be considered. They advocated the inclusion of these three descriptors in the diagnosis of sexual dysfunction, as they have important therapeutic implications. They noted that these descriptors may or may not prove to be etiologically important.

Presentation Notes: Also important to consider is whether a sexual disorder is lifelong or acquired, situational or generalized. The degree of distress should also be ascertained. Women with apparently similar dysfunctions report highly variable levels of distress, which is important for diagnosis and treatment. At a minimum, distress should be noted on a scale ranging from none to mild, moderate, or severe. Sexual distress should be differentiated from nonsexual distress and depression.

Presentation Notes: At the conclusion of a lecture based on this curriculum, participants should be able to:, Describe two models of female sexual response, List four variables that affect female sexual function, Name two treatments for female sexual disorders,

Presentation Notes: At the conclusion of a lecture based on this curriculum, participants should be able to:, List two barriers that prevent effective provider/patient communication about sexual health, List three questions to ask to begin the assessment of sexual health during a clinical visit,

Presentation Notes: The health care profession has entered a new era of interest in sexuality, particularly for women. Although everyone is talking about sex, healthy sexuality and sexual problems remain areas of controversy, especially in regard to midlife and older women. The reasons include:, an early, incorrect assumption by Masters and Johnson that female sexual response proceeds in much the same linear way as male sexual response;, a dearth of data;, extrapolation of many of the existing data from research findings in men;, the absence of objective, sensitive, and reliable criteria for evaluating female sexual response; and, a prevailing belief that older adults lose their interest in sex. Clinicians may not bring up sexual issues with midlife and older women for a variety of reasons, including personal issues and because they believe they lack the skills or time.

Presentation Notes: This slide lists prevalence data we have available on women’s sexual disorders.

Presentation Notes: The National Health and Social Life Survey (NHSLS), conducted in 1992, was a study of adult sexual behavior in the United States. It was the first population-based assessment of sexual dysfunction since the Kinsey study 50 years prior. It was an in-person survey of sexually-active people ages 18-59 and included 1,749 women and 1,410 men. Respondents were asked if they had problems in any one of seven areas of sexual function in past 12 months. It found that 43 percent of women and 31 percent of men had sexual difficulty within the past year. These statistics are widely quoted. The study found that for women, the prevalence of sexual problems tends to decrease with increasing age, except for those who report trouble with vaginal lubrication. Unmarried women and younger women experienced more sexual problems than married and older women. Black women tend to have higher rates of low sexual desire and experience less pleasure compared with white women; white women reported more sexual pain than black women. Hispanic women had consistently lower rates of sexual problems.

Presentation Notes: Among the other limitations listed here, the survey is limited by the fact that only yes or no answers were elicited to questions about sexual functioning in seven areas. It is unclear if the problems were only occasional or sometimes rather than chronic. The seven areas were a lack of desire for sex, arousal difficulties, inability to have orgasm, anxiety about sexual performance, climaxing too rapidly, physical pain during intercourse, and not finding sex pleasurable. Positive responses to the questions did not connote a clinical definition or diagnosis of a sexual disorder. The nature of the questionnaire probably reflects normal variations in sexual function in the US rather than disorders that happen all the time.

Presentation Notes: One of the issues with female sexual function has been the difficulty of determining when a sexual behavior becomes a sexual problem. Most experts agree that a critical attribute of any sexual function diagnosis is dependent on whether the condition actually causes the woman distress. Without distress, a diagnosis and treatment are not required. In 1999–2000, the Kinsey Institute conducted a telephone survey of 987 black and white women aged 20 to 65 who had been in a heterosexual relationship for 6 months or more. A quarter of women (24.4%) surveyed reported marked distress about their sexual relationship, their own sexuality, or both. The most reliable predictors of sexual distress were markers of general emotional well-being (depression, tiredness, general unhappiness) and the emotional relationship with their partner while engaged in sexual activity. Poor predictors of distress were physical aspects of sexual response in women, such as arousal, vaginal lubrication, and orgasm. Sexual problems were defined as no sexual thoughts, no orgasm, lubrication problems, impaired physical response, and pain. Sexual thoughts occurred less frequently as women aged. Lubrication problems increased as women aged, but not significantly over the level reported by younger women. Overall, the authors noted that reduced sexual interest or response were less a cause of distress to older women than to younger women.

Presentation Notes: Assessment of sexual problems has been neglected in clinical trials due to lack of sensitive and reliable outcome measures, because there is no defining physical event to measure arousal and orgasm in women as there is for men with penile erection. There is far less literature on functioning and treatment of sexual problems for women than for men: A Medline search yields approximately 5,000 references for female sexual disorders and 14,000 references for male sexual disorders. There is also a lack of agreement on the definition of terms such as “desire,” “satisfaction,” and “orgasm” for women. This is all changing as researchers and providers are challenging existing beliefs about female sexuality and new treatments and drugs are being developed.

Presentation Notes: The American Foundation for Urologic Disease gathered a group of international experts from multiple disciplines to review the data on women’s sexual disorders and challenge some of the existing beliefs about female sexuality. The results were published in 2003. This slide lists some of the myths that persist about female sexuality. In reality, we now know that the pathogenesis of sexual dysfunction is often unclear in women and can involve multiple psychological, interpersonal, and organic contributions. Psychological and organic influences are not necessarily separate entities. Women’s sexual motivation appears to be highly complex and highly varied. Women in new relationships report internal feelings of desire in terms of sexual thoughts and fantasies more than women in established relationships. The majority of sexually healthy women in longer-term relationships report infrequent spontaneous sexual thinking. In actuality, arousal often precedes desire for women, or they may coexist and reinforce one another. Women have a wide variety of motives other than desire for agreeing to sexual activity.

Presentation Notes: This slide continues the list of myths that persist about healthy sexuality. Subjective arousal does not necessarily correlate with genital response in women. Women’s sexual arousal varies and includes several components, such as sexual excitement. Women also have variable awareness of physiological changes in the body, such as vasocongestion in the genitals and breasts. Direct awareness of physiological changes may not be proportional to increased vaginal engorgement as measured by vaginal photoplethysmography. Vaginal lubrication typically occurs whether sexual stimulation is desired and enjoyed or not. Women’s sexual response is actually discontinuous across the reproductive and sexual life cycle and influenced by the context of any actual or potential sexual interaction, normal reproductive events, medical conditions, and psychological factors (most notably the interpersonal relationship). There is also a normative and gradual lessening of sexual interest and response with aging and natural menopause. Subjective distress about sexual response varies depending on a variety of factors. Lack of response or interest in sex that is not problematic to the woman has little clinical relevance.

Presentation Notes: When a woman is sexually aroused, an increase in blood flow to the genitals results in engorgement of the labia minora and clitoris. The vagina lengthens and widens to accommodate the penis, and lubricating secretions coat the walls of the vagina. The uterus rises over the levator plate. It is now known that the clitoris is a complex organ that extends deep into the pelvic structure. It has 18 different (and many hidden) components, and contains 8,000 nerve fibers—twice as many as the penis. Although the clitoris is an erectile organ similar to the penis, it does not become rigid when engorged because it lacks a mechanism for trapping blood. The sole purpose of the clitoris appears to be to produce sexual pleasure, and the majority of women require stimulation of the clitoris in order to experience orgasm.

Presentation Notes: Excitement can last for a few minutes to several hours and is characterized by a variety of physical changes that prepare a woman’s body for orgasm. Plateau is characterized by the intensification of the changes begun during the excitement phase; this phase extends to the brink of orgasm. Orgasm is the peak of sexual excitement and begins the reversal of the changes begun during the excitement phase. Resolution is the final phase when the body returns to an unexcited state. This diagram reflects the responses different women can have or an individual woman can have on different occasions. For instance, Woman A has a smooth transition from excitement to plateau to orgasm to resolution and has multiple orgasms on this occasion. Woman B (or Woman A on a different occasion) has a smooth transition up to plateau but doesn’t experience orgasm. This is not a problem if it is an occasional occurrence (e.g. it is Woman A who sometimes experiences orgasm) but would be diagnosed as a sexual disorder if this occurs every time Woman B has a sexual experience. Woman C has a different pattern of transition from excitement through orgasm and resolution than either A or B—again possibly reflecting the same woman on another occasion or three different women. Pattern C usually occurs with masturbation.

Presentation Notes: The linear model has been called into question for a number of reasons:, – It assumes women and men have similar sexual responses. – It assumes women move progressively and sequentially through the phases as described. – It is solely a biologic model that doesn’t take into account psychosocial effects on sexual response.

Presentation Notes: Dr. Rosemary Basson of the University of British Columbia has constructed a new circular model of female sexual response that incorporates the importance of emotional intimacy, sexual stimuli, and relationship satisfaction. This model acknowledges that female sexual functioning proceeds in a more complex and circuitous manner than male sexual functioning and is affected by numerous psychosocial issues (e.g. satisfaction with relationship, self-image, previous sexual experiences, etc.). According to Basson, women have many reasons for engaging in sexual activity other than sexual hunger or drive. Many midlife women in long-term relationships do not have a great deal of spontaneous desire and interest, but engage in sex due to a desire for increased emotional intimacy with their partner. They start from a position of sexuality neutrality, where they are responsive to engaging in sexual activity if their partners approach them but don’t initiate sexual activity. Once aroused, sexual desire emerges and motivates them to continue the activity. This model clarifies how vulnerable a woman’s sexual response is and that the goal of sexual activity for women is not necessarily orgasm, but rather personal satisfaction.

Presentation Notes: Sexuality for women extends far beyond the release of neurotransmitters, the influence of sex hormones, and vasocongestion of the genitals. A number of psychological and sociological variables can affect female sexual function. Among the psychosocial variables, perhaps the most important is the relationship with the sexual partner. According to Basson, emotions and thoughts have a stronger impact on a woman’s assessment of whether or not she is aroused than does genital vasocongestion.

Presentation Notes: These are other factors that affect female sexual response, according to Rosemary Basson, such as:, feelings of safety, emotions associated with arousal, stress or fatigue, depression or anxiety disorders

Presentation Notes: In the past, much of our information about sexuality at perimenopause and beyond has been based on anecdotal complaints from a small, self-selecting group of symptomatic women who presented to providers. Today, we have large population-based studies that offer a more accurate picture—and show that aging does not have to signal the end of sexual interest or activity. Although many studies do show a normative, gradual decline in sexual desire and activity with age, research also indicates that the majority of men and women who are healthy and have partners will remain interested in sex and engage in sexual activity well into midlife, later life, and until the end of life. A Kinsey Institute survey found that emotional well-being and the quality of a relationship with a partner had more of an impact on sexuality than aging. A number of changes that occur with aging have effects on sexual response—e.g. genital atrophy, thinning of vaginal mucosa, decreased muscle tension—but most studies do not show an appreciable rise in sexual problems as women age.

Presentation Notes: This slide shows findings from the Duke Longitudinal Study of 261 white men and 241 white women between the ages of 46 and 71. For women, sexual activity declined with age because of they lacked a partner or their partner was unable to perform sexually. For men, sexual activity declined significantly with age because they were unable to perform (40 percent). Regression analysis showed that marital status was the primary factor leading to reduction in sexual interest, enjoyment, and frequency of intercourse among women, followed by age and education. Health was not a factor for women, and postmenopausal status was identified as a small contributor leading to lower levels of sexual interest and frequency but not to enjoyment. For men, age, was the primary factor, followed by present health.

Presentation Notes: This slide lists some of the changes that occur with aging that affect female sexual response:, Clitoral shrinkage, decrease in perfusion and engorgement, delay in clitoral reaction time, Decreased vascularization and delayed or absent vaginal lubrication, Decreased vaginal elasticity, thinning of vaginal mucosa, Decreased sex drive, erotic response, tactile sensation, capacity for orgasm, Despite these changes, most current studies do not show an appreciable rise in sexual problems as women age.

Presentation Notes: Although menopause symptoms can indirectly affect sexual responsiveness, as with aging, menopause does not represent an end of sex. Declining estrogen and testosterone levels may be associated with a diminished sex drive, but in light of Basson’s recent model of female sexual response, this may not be as important an occurrence as once thought. If desire is not the motivating force for sexual activity for many women, as Basson contends, then the loss of spontaneous desire may not have much impact on a woman’s sexual life if her partner is still interested in engaging in sex.

Presentation Notes: The Study of Women’s Health Across the Nation (SWAN) investigated the sexual behavior of 3,262 nonhysterectomized women aged 42 to 52 who were not using hormones. Early perimenopausal women reported more frequent dyspareunia than premenopausal women, but there were no differences between the two groups in regard to sexual desire, satisfaction, arousal, physical pleasure, or the importance of sex. Overall, as seen in the graph, 79 percent had engaged in sex with a partner within the past 6 months. Seventy-seven percent said sex was moderately to extremely important to them, although 42 percent reported a desire for sex infrequently (0 to 2 times per month). The authors noted that a “lack of frequent desire does not appear to preclude emotional satisfaction and physical pleasure with relationships.”

Presentation Notes: Results of the Massachusetts Women’s Health Study II (MWHS II) are shown on this slide. Studied 200 pre-, peri-, and postmenopausal women, The presence of vasomotor symptoms was not related to any aspect of sexual functioning. Menopause status had less impact on sexual functioning than health, marital status, mental health, smoking. Menopause can indirectly affect sexual response, but recent studies suggest that the hormonal changes (reduced estrogen and testosterone production) that occur during menopause have less effect on a woman’s sexual life and response than do her feelings about herself, her partner, whether her partner has sexual problems, and her overall feelings of well-being, Satisfaction with sex life, frequency of intercourse, pain during intercourse did not vary by menopausal status

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Presentation Notes: This slide compares mean steroid levels in reproductive vs. postmenopausal women.

Presentation Notes: A4 =androstenedione. % represents reduction from premenopausal level. By age 50, testosterone levels are reduced by half in women, compared with age 20. The role of testosterone in causing sexual problems in women is unclear. It is not well understood what constitutes an androgen deficiency or normal ranges of androgens in women.

Presentation Notes: Although psychosocial factors are the focus of much discussion today in the pathogenesis of sexual disorders, physical factors remain important and cannot be dismissed. A variety of medical conditions can directly or indirectly affect female sexual functioning and satisfaction. For instance, by impairing blood flow, a vascular disease such as hypertension or an endocrine disorder such as diabetes might inhibit the ability to become aroused.

Presentation Notes:

Presentation Notes: This slide lists the medications that can affect a woman’s desire for sex. Psychoactive Medications, Antipsychotics, Barbiturates, Benzodiazepines, Lithium, SSRIs, Tricyclic antidepressants, Hormonal Agents, Danazol, GnRh agonists, Oral contraceptives, Cardiovascular Medications, Antilipid drugs, Beta blockers, Clonidine, Digoxin, Spironolactone, Others, H2-receptor blockers, Indomethacin, Ketoconazole, Phenytoin sodium

Presentation Notes: This slide lists the medications that can affect a woman’s ability to become aroused in response to sexual stimuli. Anticholinergics, Antihistamines, Antihypertensives, Psychoactive medications, Benzodiazepines, MAO inhibitors, SSRIs, Tricyclic antidepressants

Presentation Notes: This slide lists the medications that can affect a woman’s ability to experience orgasm. Tricyclic antidepressants are also associated with painful orgasm.

Presentation Notes: The National Health and Social Life Survey (NHSLS) looked at variables that may be predictive of female sexual problems. Sexual problems were more common among younger women, perhaps due to inexperience, a lack of a steady partner, and periods of sexual inactivity. Unmarried women were also more likely to have sexual problems than married women. Women with poor health had an increased risk of sexual pain disorders, and those with urinary tract symptoms were at greater risk for arousal and pain disorders. Low sexual activity or interest was predictive of a desire or arousal disorder. Deteriorating economic status was positively associated with a modest elevation in the risk of all categories of sexual problems. Negative sexual experiences were highly associated with arousal problems. Emotional and stress-related problems also increased the risk of sexual difficulties.

Presentation Notes: The Massachusetts Women’s Health Survey II found that health and marital status were the most consistent predictors of continuing sexual activity among 200 premenopausal, perimenopausal, and postmenopausal women. The better a woman’s health, the more likely she was to have interest in sex and engage in sex. Marriage had the opposite effect: Married women had lower libidos than single women and were more likely to say that interest in sex declines with age and to report that they were less aroused now than when they were in their 40s.

Presentation Notes: The American Psychiatric Association’s DSM-IV: Diagnostic and Statistical Manual, 4th edition, published in 1994, contains a classification for female sexual disorders that is based on the Masters and Johnson and Kaplan linear model of female sexual response. The DSM-IV, which focuses on psychiatric disorders, defines a female sexual disorder as a “disturbance in sexual desire and in the psychophysiological changes that characterize the sexual response cycle and cause marked distress and interpersonal difficulty.”, This classification has increasingly come under scrutiny and criticism.

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Presentation Notes: In 1999, the American Foundation for Urologic Disease convened an international multidisciplinary panel of 19 experts in female sexual disorders to evaluate and revise the existing definitions for female sexual disorders from the DSM-IV. This consensus conference was supported by educational grants from several pharmaceutical companies. Like previous classifications, the Consensus-based Classification of Female Sexual Dysfunction (CCFSD) is based on the Masters and Johnson and Kaplan linear model of female sexual response, which is problematic. However, the CCFSD system represents an advance over older classifications because it incorporates both psychogenic and organic causes of desire, arousal, orgasm, and sexual pain disorders. The diagnostic system also has a “personal distress” criterion, indicating that a condition is considered a disorder only if a woman is distressed by it.

Presentation Notes:

Presentation Notes: Patient sexuality issues can be difficult and daunting for a provider to explore, but accurate diagnosis and effective treatment hinge on good communication between provider and patient, as well as between the patient and her sexual partner. Many providers say they don’t broach sexuality issues because they feel personal discomfort with the subject; lack training, skills, and time to deal with human sexuality concerns; fear offending the patient; have no treatments to offer; or believe that sexual interest and activity naturally decline with age.

Presentation Notes: When talking about sexuality with a patient, do not assume that just because she is over 50 or menopausal that she is sexually inactive. Also, do not assume that she is in a heterosexual relationship. Many older women may be in lesbian relationships or are bisexual. Others may not be in long-standing relationships and may be at risk for sexually transmitted infections. Be sensitive to her cultural issues. Arab women, for instance, may be unable to discuss sexual issues with a male provider or with a male in the room. Asian women may be uncomfortable verbalizing their concerns or experiences concerning sexuality. Other cultures may be uncomfortable with oral sex when suggested as an alternative sexual expression to intercourse. Careful use of language, eye contact, and body language would be helpful to ease anxieties when discussing sexuality.

Presentation Notes: A survey by Marwick showed that 68 percent of patients don’t bring up sexuality issues with providers because they fear embarrassing the provider. Seventy-one percent of the respondents believe their providers would just dismiss their sexual concerns.