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Safety and Efficacy of a Testosterone Patch for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
A Randomized, Placebo-Controlled Trial
Glenn D. Braunstein, MD;
Dale A. Sundwall, MD;
Molly Katz, MD;
Jan L. Shifren, MD;
John E. Buster, MD;
James A. Simon, MD;
Gloria Bachman, MD;
Oscar A. Aguirre, MD;
Johna D. Lucas, MD;
Cynthia Rodenberg, PhD;
Akshay Buch, PhD;
Nelson B. Watts, MD
Arch Intern Med. 2005;165:1582-1589.
Background Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women.
Methods A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 µg/d (n = 107), 300 µg/d (n = 110), or 450 µg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures.
Results Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-µg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P = .05) and in frequency of satisfying sexual activity (79% vs 43%; P = .049). The 150-µg/d group showed no evidence of a treatment effect. The 450-µg/d group also was not statistically different from the 300-µg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P = .06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed.
Conclusions The 300-µg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.
Author Affiliations: Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif (Dr Braunstein); Physicians Research Options, Sandy, Utah (Dr Sundwall); Katz, Kade, and Hewitt Inc, Cincinnati, Ohio (Dr Katz); Vincent Memorial Obstetrics and Gynecology Service, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston (Dr Shifren); Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Tex (Dr Buster); Women’s Health Research Center, Laurel, Md (Dr Simon); Women’s Health Institute, University of Medicine and Dentistry of New Jersey, New Brunswick (Dr Bachman); Urogynecology Associates of Colorado, Denver (Dr Aguirre); Procter & Gamble Pharmaceuticals, Health Care Research Center, Mason, Ohio (Drs Lucas, Rodenberg, and Buch); and University of Cincinnati Osteoporosis Center, Cincinnati (Dr Watts).
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