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,multicentertrialwasconducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingooophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n=119) or testosterone patches in dosagesof150µg/d(n=107),300µg/d(n=110),or450µg/d (n=111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures. Results:Ofthe447womenrandomized,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 doseresponse 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.