1. Androgen Therapy for Low Sexual Desire: A Concerned Physician’s View James A. Simon, M.D. Clinical Professor George Washington University Washington, DC Medical Director The Women’s Health Research Center Laurel, MD

2. Issues Is low sexual desire really a clinical problem for women? Beyond clinical concerns about acne, and hirsutism, does androgen therapy increase a woman’s risk of breast cancer? Personal Perspective

3. Prevalence of Sexual Dysfunction in Women Laumann EO, et al. JAMA. 1999;281:537-544. *Women aged 18-59 years 32% 28% 21% 27% Percentage of Women* 43% of Women Experience Some Form of Sexual Dysfunction

4. Sexual Behavior and Sexual Dysfunctions After Age 40: The Global Study of Sexual Attitudes and Behaviors Objective: To assess the importance and prevalence of sexual dysfunction among middle aged and older adults around the world Data were collected in 29 countries from 27,500 men and women aged 40-80 using questionnaires Sexual dysfunction was defined as “frequent and persistent problems Sexual dysfunctions studied in women were: ● Lack of sexual interest ● Lubrication difficulties and pain during intercourse ● Inability to achieve orgasm From: Nicolosi, Laumann, Glasser, et al. Urology 64: 991-997, 2004

5. Sexual Behavior and Sexual Dysfunctions After Age 40: The Global Study of Sexual Attitudes and Behaviors Results (women): 65% of the women had sexual intercourse during the past year The most common sexual dysfunctions found in women were: ● Lack of sexual interest (21%) ● Lubrication difficulties and pain during intercourse (16%) ● Inability to achieve orgasm (16%) Conclusion: Overall 39% of the women said they were affected by at least one sexual dysfunction From: Nicolosi, Laumann, Glasser, et al. Urology 64: 991-997, 2004

6. Breast Cancer Incidence in Postmenopausal Women Using Testosterone in Addition to Usual Hormone Therapy Objective: To determine if testosterone protects women from breast cancer when added to standard hormone therapy Design: Retrospective, observational trial of 508 postmenopausal women receiving testosterone therapy (average age 56.4; mean follow-up 5.8 years) Outcomes: Breast cancer incidence with testosterone compared to nonusers and standard hormone therapy users from the literature From: Dimitrakakis, Jones, Liu and Bondy. Menopause: 11: 531-535, 2004

7. Breast Cancer Incidence in Postmenopausal Women Using Testosterone in Addition to Usual Hormone Therapy Results: expressed as rate/100,000 women-years ● On testosterone: 238 ● On testosterone, estrogen/progestin: 293 ● On estrogen/progestin (from WHI): 380 ● On estrogen/progestin (from Million Women Study): 521 ● Never users (from Million Women Study): 283 Conclusions: “…the addition of testosterone to conventional hormone therapy for postmenopausal women does not increase and may indeed reduce the hormone therapy-associated breast cancer risk-thereby returning the incidence to the normal rates observed in the general, untreated population” From: Dimitrakakis, Jones, Liu and Bondy. Menopause: 11: 531-535, 2004

8. Summary and Conclusions There is a serious need for safe and effective therapies for all aspects of sexual dysfunction in women Low sexual desire is a very common complaint of postmenopausal women affecting more than 20% of women over age 40 While hormone therapy appears to increase the risk of breast cancer, the addition of testosterone does not appear to increase this risk.