Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen: A Phase III Study of Female Sexual Dysfunction on Testosterone Patch Without Estrogen (APHRODITE)

The study investigated the effects of a testosterone patch on postmenopausal women with hypoactive sexual desire disorder who were not taking estrogen. In this double-blind, randomized, placebo-controlled trial, 814 participants received either 150 or 300 mcg of testosterone or a placebo for 52 weeks. Results showed that 300 mcg of testosterone significantly increased the frequency of satisfying sexual episodes compared to placebo (2.1 vs. 0.7 episodes, P < .001) and improved sexual desire and reduced personal distress. The 150 mcg dose also improved sexual desire and reduced distress but did not significantly increase satisfying episodes. Androgenic adverse events, mainly hair growth, were more common in the 300 mcg group. Four cases of breast cancer were detected in the testosterone group, with none in the placebo group. The study concluded that testosterone provided modest benefits for sexual function without the need for estrogen therapy.