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)

Abstract

Few meaningful data are available on the use of testosterone for treatment of postmenopausal women with hypoactive sexual desire disorder not receiving estrogen or estrogen plus progestin. This double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in women with natural or surgically induced menopause who were not receiving estrogen or estrogen plus progestin. A total of 814 participants randomly received a patch delivering 150 or 300 mcg of testosterone per day or placebo for 52 weeks. Efficacy was measured up to week 24 and safety was evaluated over the entire 52 weeks. Daily administration of 300 mcg of testosterone from baseline to week 24 produced a significant increase in the 4-week frequency of satisfying sexual episodes compared to the placebo (2.1 episodes versus 0.7, P <.001). No significant increase in the frequency of satisfying sexual episodes was found among women receiving daily doses of 150 mcg compared to placebo (1.2 episodes, P =.11). Compared to placebo, both groups of women receiving testosterone had significant increases at 24 weeks in scores for sexual desire (300 mcg per day, P <.001; 150 mcg per day, P <.04) and significant decreases in scores for personal distress (300 mcg per day, P <.001; 150 mcg per day, P <.04). The overall incidence of androgenic adverse events, primarily hair growth, was higher in the group receiving 300 mcg of testosterone per day than in the placebo group (30.0% versus 23.1%). Breast cancers were detected in 4 women who had received testosterone; 1 of the 4 had symptoms before randomization and one was diagnosed after only 4 months of therapy. None of the women who received placebo were diagnosed with breast cancer. The data show that testosterone has a modest but meaningful benefit in sexual function of postmenopausal women not receiving estrogen therapy. Concomitant estrogen or combined estrogen and progestin may not be required.