Susan R. Davis, M.D., Ph.D., Michele Moreau, M.D., Robin Kroll, M.D., Céline Bouchard, M.D., Nick Panay, M.D., Margery Gass, M.D., Glenn D. Braunstein, M.D., Angelica Linden Hirschberg, M.D., Ph.D., Cynthia Rodenberg, Ph.D., Simon Pack, Ph.D., Helga Koch,
BACKGROUND: The efficacy and safety of testosterone treatment for hypoactive sexual desire dis- order in postmenopausal women not receiving estrogen therapy are unknown.
METHODS: We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. Efficacy was measured to week 24; safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes.
RESULTS: At 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. 0.7, P