Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: A randomized, placebo-controlled trial

Glenn D. Braunstein, Dale A. Sundwall, Molly Katz, Jan L. Shifren, John E. Buster, James A. Simon, Gloria Bachman, Oscar A. Aguirre, Johna D. Lucas, Cynthia Rodenberg, Akshay Buch, Nelson B. Watts

Research output: Contribution to journalArticlepeer-review

346 Scopus citations

Abstract

Background: Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women. Methods: A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n=119) or testosterone patches in dosages of 150 μg/d (n=107), 300 μg/d (n=110), or 450 μg/d (n=111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures. Results: Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-μg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P=.05) and in frequency of satisfying sexual activity (79% vs 43%; P=.049). The 150-μg/d group showed no evidence of a treatment effect. The 450-μg/d group also was not statistically different from the 300-μg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P=.06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed. Conclusions: The 300-μg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.

Original languageEnglish (US)
Pages (from-to)1582-1589
Number of pages8
JournalArchives of Internal Medicine
Volume165
Issue number14
DOIs
StatePublished - Jul 25 2005

All Science Journal Classification (ASJC) codes

  • Internal Medicine

Fingerprint Dive into the research topics of 'Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: A randomized, placebo-controlled trial'. Together they form a unique fingerprint.

Cite this