Objective:

To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause.

Design:

A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N= 549). Women were randomized to receive testosterone 300 μg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24).

Results:

A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels≤ 160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels≤ 160 nmol/L, mean change of 2.1±0.28 versus 0.5±0.23 episodes/4 weeks; P< 0.0001; intent-to-treat population, mean change from baseline of 1.9±0.26 versus 0.5±0.21 episodes/4 weeks, P< 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated.

Conclusions:

Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.