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

This study evaluated the efficacy and safety of a testosterone patch for treating hypoactive sexual desire disorder in 814 postmenopausal women not receiving estrogen or estrogen plus progestin. Over 52 weeks, women received either a placebo or a patch delivering 150 or 300 mcg of testosterone daily. The 300 mcg dose significantly increased the frequency of satisfying sexual episodes (2.1 vs. 0.7 episodes, P < .001) and improved sexual desire and reduced personal distress scores at 24 weeks. The 150 mcg dose showed no significant increase in sexual episodes but did improve desire and distress scores. Androgenic adverse events, mainly hair growth, were more common in the 300 mcg group (30.0% vs. 23.1%). Four cases of breast cancer were detected in the testosterone groups, with none in the placebo group. The study concluded that testosterone provides a modest but meaningful benefit in sexual function for postmenopausal women not on estrogen therapy.