Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women - A randomized, placebo-controlled trial

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 mu g/d (n= 107),300 mu g/d (n= 110), or 450 mu g/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-mu g/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-mu g/d group showed no evidence of a treatment effect. The 450-mu g/d group also was not statistically different from the 300-mu g/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-mu g/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.