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Testosterone Therapy for Hypoactive Sexual Desire Disorder

Testosterone Therapy for Hypoactive Sexual Desire Disorder. Introduction. Rationale for use Combination estrogen-testosterone therapy Testosterone use in women Therapies available and under investigation Dosing/administration issues Clinical trials of testosterone use in women

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Testosterone Therapy for Hypoactive Sexual Desire Disorder

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  1. Testosterone Therapy for Hypoactive Sexual Desire Disorder

  2. Introduction • Rationale for use • Combination estrogen-testosterone therapy • Testosterone use in women • Therapies available and under investigation • Dosing/administration issues • Clinical trials of testosterone use in women • Managing side effects • Patient selection

  3. Rationale for Testosterone Therapy • Testosterone levels in women decline with aging • Women in their 40s have approximately one-half the level of women in their 20s • Women who undergo oophorectomy experience dramatic decreases in the level of testosterone • Level of testosterone decreases to one half of those prior to surgery Zumoff B, et al. J Clin Endocrinol Metab. 1995;80:1429-1430. Judd HL, et al. J Clin Endocrinol Metab. 1974;39:1020-1024.

  4. Rationale for Testosterone Therapy (cont’d) • Testosterone has been linked to sexual desire and coital frequency in menopausal women • Accumulating data indicate that testosterone therapy increases sexual function, including sexual desire, in postmenopausal women • McCoy NL, et al. Maturitas. 1985;7:203-210. • Shifren JL, et al. N Engl J Med. 2000;343:682-688. • Lobo RA, et al. Fertil Steril. 2003;79:1341-1352.

  5. Combination Estrogen-Testosterone Therapy

  6. Impact of Estrogen Deficiency on Sexual Function • Changes in urogenital anatomy • Shortening and loss of elasticity of the vagina • Diminished secretions • Increased pH • Thinning of vaginal epithelial layers • Reduced blood flow • Reduced nerve transmission and discharge • Sleep disruption • Mood alterations Sarrel PM. Obstet Gynecol. 1990;75:26S-30S. Bachmann GA, et al. Menopause. 2004;11:120-130.

  7. Percentage of Women Reporting Problems N=93; significance not reported. Low Estrogen Is Associated With Increased Prevalence of Sexual Problems Sarrel PM. J Womens Health Gend Based Med. 2000;9:S25-S32. Sarrel PM. Obstet Gynecol. 1990;75:26S-30S.

  8. Low-Dose EE High-Dose EE Low-Dose EE + MT High-Dose EE + MT Placebo * * * * * Postplacebo run-in period * * Month 1 * Month 3 N=93; *P≤0.05 EE=esterified estrogens; MT=methyltestosterone Efecto de Terapia con Estrógenos and Estrógenos-Andrógenos sobre Síntomas menopaúsicos Simon J, et al. Menopause. 1999;6:138-146.

  9. Testosterone Use in Women

  10. Oral Methyltestosterone Testosterone undecanoate Intramuscular Testosterone propionate Testosterone cypionate Testosterone enanthate Subcutaneous (implant) Testosterone propionate pellets Testosterone crystalline pellets Transdermal Transdermal testosterone patch Testosterone gel Testosterone emulsion Testosterone spray Other Testosterone-containing vaginal ring Sublingual testosterone in propylene glycol Testosterone Therapies Available and Under Investigation* * Not approved by US Food and Drug Administration for use in women.

  11. Estrógenos y Enantato de Testosterona: Deseo sexual Estrógeno Inyeccion 5 Estrógeno + TE Control 4 3 Niveles medios de Deseo Sexual 2 1 0 B 1 2 3 4 Semanas N=65; TE=testosterona enantato Sherwin BB, et al. Psychosom Med. 1987;49:397-409.

  12. Summary Statistics Libido Estrogen Activity Estrogen +testosterone Satisfaction Pleasure Fantasy Orgasm Relevancy 5 6 7 8 9 10 Sexuality Score (Means of 6, 12, 18, and 24 Months) N=34 Estradiol and Testosterone Implants:Sexual Function Davis SR, et al. Maturitas. 1995;21:227-236.

  13. Estrogen and Methyltestosterone:Effect on Testosterone Levels N = 107 N = 111 EE=esterified estrogens; MT=methyltestosterone Lobo RA, et al. Fertil Steril. 2003;79:1341-1352.

  14. 0.9 * EE (n = 111) 0.6 EE+MT (n = 107) Mean Change 0.3 0 4 8 12 16 Study Week *P<0.02 vs baseline Estrogen and Methyltestosterone:Sexual Desire EE=esterified estrogens; MT=methyltestosterone Lobo RA, et al. Fertil Steril. 2003;79:1341-1352.

  15. Estrogen and Methyltestosterone:Frequency of Interest/Desire † † EE (n = 111) EE+MT (n = 107) * Study Week *P<0.02 vs baseline; †P<0.01 vs baseline Lobo RA, et al. Fertil Steril. 2003;79:1341-1352. EE=esterified estrogens; MT=methyltestosterone

  16. 3.5 EE * 3 EE+MT 2.5 2 * Change in Raw Score From Previous Hormone Therapy 1.5 † 1 0.5 0 Sensation Sensation Desire Frequency Vaginal -0.5 Changes and Desire N=20; *P<0.01; †P≤0.05 Estrogen and Methyltestosterone: Sexual Functioning EE=esterified estrogens; MT=methyltestosterone Sarrel PM, et al. J Reprod Med. 1998;43:847-856.

  17. Placebo Baseline 150 mcg 300 mcg 8 14 * * 7 12 6 10 5 * * 8 Bioavailable T (ng/dL) Free T (pg/mL) 4 6 3 4 2 2 1 0 0 Regime n (+CEE) Regimen (+CEE) N=75; *P<0.001 for comparison with placebo CEE=conjugated equine estrogens; T=testosterone Endocrine Sciences normal range for cycling women Estrogen and Testosterone Patch: Free and Bioavailable Testosterone Levels Shifren JL, et al. N Engl J Med. 2000;343:682-688.

  18. Baseline 150 mcg Placebo 300 mcg 120 110 100 * 90 Percentage of Normative Mean 80 * 70 60 50 40 Arousal Frequency Thoughts/ Desires Problems Pleasure/ Orgasm N=75; *P<0.05 for comparison with placebo Oral Estrogen and Testosterone Patch: Sexual Function Shifren JL, et al. N Engl J Med. 2000;343:682-688.

  19. Oral Estrogen and Testosterone Patch: Effect on Sexual Function SM=surgically menopausal; HSDD=hypoactive sexual desire disorder; T=testosterone Braunstein GD, et al. In: Program and abstracts of the 14th annual meeting of the North American Menopause Society; September 17-20, 2003; Miami Beach, Fla. Abstract 60. Davis S, et al. Fertil Steril. 2003;80(suppl 3):76.

  20. Oral Estrogen and Testosterone Patch: Effect on Sexual Function (cont’d) SM=surgically menopausal; HSDD=hypoactive sexual desire disorder; T=testosterone Simon JA, et al. Obstet Gynecol. 2004;103(suppl):64S. Buster J, et al. In: Program and abstracts of the 86th annual meeting of the Endocrine Society; June 16-19, 2004; New Orleans, La. Abstract OR44-6.

  21. Baseline * EV * EV + TU * McCoy Sex Scale Score (Mean) *P<0.05 vs EV at 24 weeks N=50; EV-estradiol valerate; TU-testosterone undecanoate Estrogen and Testosterone Undecanoate: Sexual Function Satisfaction With Frequency of Sex Enjoyment of Sex Interest in Sex Floter A, et al. Climacteric. 2002;5:357-65.

  22. Potential Side Effects With Testosterone Therapies • Hirsutism • Acne • Voice deepening • Alopecia • Liver toxicity • Negative effects on lipoproteins • Clitoromegaly

  23. Side Effects in Studies With Testosterone Therapies • Few side effects are reported in studies • Increased doses are associated with • Facial hair • Acne/oily skin • Oral preparations • Decreases in high-density lipoprotein • Not seen with transdermal preparations

  24. Placebo Baseline 150 mcg 300 mcg 2.5 * 2.0 1.5 1.0 Mean Score (SEM) 0.5 0.0 Hirsutism Acne Facial Depilation (Lorenzo Scale) (Palatsi Scale) (Times/Month) N=75; *P<0.05 for comparison with placebo Estrogen and Testosterone Patch: Safety Shifren JL, et al. N Engl J Med. 2000;343:682-688.

  25. Estrogen and Methyltestosterone: Safety EE=esterified estrogens; MT=methyltestosterone Lobo RA, et al. Fertil Steril. 2003;79:1341-1352.

  26. Patient Selection • Testosterone therapy, in conjunction with estrogen therapy, may be indicated in women with: • Surgical menopause • Decreased libido • Diminished sense of well-being

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