Testosterone therapy is an effective treatment for low libido in postmenopausal women, suggest results of an international study of more than 800 women.
Previous research has shown that testosterone therapy is useful for restoring libido in women when used in conjunction with estrogen replacement therapy. However, this study is the first to show that testosterone by itself can enhance sexual wellbeing in postmenopausal women.
For the year-long study researchers randomly assigned 814 women with hypoactive sexual desire disorder to receive a skin patch delivering 150 or 300 µg of testosterone per day or placebo. The primary endpoint of the study was the change from the start of the study to week 24 in the 4-week frequency of satisfying sexual episodes.
Results showed that women receiving 300 µg of testosterone per day experienced a significant increase in satisfying sexual episodes compared to women receiving the placebo (2.1 episodes versus 0.7). Women receiving 150 µg testosterone per day did experience an increase in satisfying sexual episodes (1.2 episodes), however the increase was not statistically significant. In comparison with the placebo group, women receiving both doses of testosterone experienced significant increases in desire.
The researchers concluded: “In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 µg of testosterone per dayresulted in a modest but meaningful improvement in sexual function.”
Davis SR, Moreau M, Kroll R, et al. Testosterone for low libido in postmenopausal women not taking estrogen. NEJM 2008:359:2005-2017.
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, Ph.D., Alain Moufarege, M.D., John Studd, M.D., for the APHRODITE Study Team
Background The efficacy and safety of testosterone treatmentfor hypoactive sexual desire disorder in postmenopausal womennot receiving estrogen therapy are unknown.
Methods We conducted a double-blind, placebo-controlled, 52-weektrial in which 814 women with hypoactive sexual desire disorderwere randomly assigned to receive a patch delivering 150 or300 µg of testosterone per day or placebo. Efficacy wasmeasured to week 24; safety was evaluated over a period of 52weeks, with a subgroup of participants followed for an additionalyear. The primary end point was the change from baseline toweek 24 in the 4-week frequency of satisfying sexual episodes.
Results At 24 weeks, the increase in the 4-week frequency ofsatisfying sexual episodes was significantly greater in thegroup receiving 300 µg of testosterone per day than inthe placebo group (an increase of 2.1 episodes vs. 0.7, P<0.001)but not in the group receiving 150 µg per day (1.2 episodes,P=0.11). As compared with placebo, both doses of testosteronewere associated with significant increases in desire (300 µgper day, P<0.001; 150 µg per day, P=0.04) and decreasesin distress (300 µg per day, P<0.001; 150 µgper day, P=0.04). The rate of androgenic adverse events —primarily unwanted hair growth — was higher in the groupreceiving 300 µg of testosterone per day than in the placebogroup (30.0% vs. 23.1%). Breast cancer was diagnosed in fourwomen who received testosterone (as compared with none who receivedplacebo); one of the four received the diagnosis in the first4 months of the study period, and one, in retrospect, had symptomsbefore undergoing randomization.
Conclusions In postmenopausal women not receiving estrogen therapy,treatment with a patch delivering 300 µg of testosteroneper day resulted in a modest but meaningful improvement in sexualfunction. The long-term effects of testosterone, including effectson the breast, remain uncertain. (ClinicalTrials.gov number,NCT00131495 [ClinicalTrials.gov] .)
From the Women's Health Program, Monash University, Alfred Hospital, Prahran, Australia (S.R.D.); Centre d'Étude Clinique, Montreal (M.M.); Women's Clinical Research Center and the Menopause Center of Seattle, Seattle (R.K.); Université Laval, Quebec, QC, Canada (C.B.); Queen Charlotte's and Chelsea Hospital, London (N.P.); University of Cincinnati College of Medicine, Cincinnati (M.G.); Cedars–Sinai Medical Center, Los Angeles (G.D.B.); Karolinska University Hospital, Stockholm (A.L.H.); Procter & Gamble Pharmaceuticals, Mason, OH (C.R., S.P., H.K.); Debiopharm Group, Charenton-le-Pont, France (A.M.); and Chelsea and Westminster Hospital, London (J.S.).
Address reprint requests to Dr. Davis at the Women's Health Program, Department of Medicine, Monash University, Alfred Hospital, Commercial Rd., Prahran VIC 3181, Australia, or at firstname.lastname@example.org .
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