Safety and Efficacy of a Testosterone Patch for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

TLDR

Oophorectomy reduces serum testosterone levels. The study evaluated the efficacy and safety of transdermal testosterone for hypoactive sexual desire disorder in surgically menopausal women through a 24‑week, randomized, double‑blind, placebo‑controlled trial. Participants were randomized to receive placebo or testosterone patches at 150, 300, or 450 µg/day twice weekly for 24 weeks, with primary outcomes of sexual desire and frequency of satisfying sexual activity. Women receiving the 300‑microg/d testosterone patch showed significantly greater increases in sexual desire (67% vs 48%) and in frequency of satisfying sexual activity (79% vs 43%) compared with placebo, while the 150‑ and 450‑microg/d doses had no significant effect; adverse events were similar across groups and no serious safety concerns were observed.

Abstract

Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women.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 microg/d (n = 107), 300 microg/d (n = 110), or 450 microg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures.Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-microg/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-microg/d group showed no evidence of a treatment effect. The 450-microg/d group also was not statistically different from the 300-microg/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.The 300-microg/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.