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Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study

Shifren, Jan L. MD1; Davis, Susan R. MD2; Moreau, Michele MD3; Waldbaum, Arthur MD4; Bouchard, Celine MD5; DeRogatis, Leonard PhD6; Derzko, Christine MD7; Bearnson, Patricia MD8; Kakos, Norman MD9; O'Neill, Sheila MD10; Levine, Stephen MD11; Wekselman, Kathryn PhD12; Buch, Akshay PhD12; Rodenberg, Cynthia PhD12; Kroll, Robin MD13

doi: 10.1097/01.gme.0000243567.32828.99
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Objective: To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause.

Design: A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N = 549). Women were randomized to receive testosterone 300 μg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24).

Results: A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels ≤160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels ≤160 nmol/L, mean change of 2.1 ± 0.28 versus 0.5 ± 0.23 episodes/4 weeks; P < 0.0001; intent-to-treat population, mean change from baseline of 1.9 ± 0.26 versus 0.5 ± 0.21 episodes/4 weeks, P < 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated.

Conclusions: Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.

Testosterone patch treatment increases the frequency of satisfying sexual activity and sexual desire, decreases personal distress, and is well tolerated in naturally menopausal women with hypoactive sexual disorder.

From the 1Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA; 2Department of Medicine (CECS), Monash University, Melbourne, Australia; 3Montreal Clinical Study Center, Montreal, Quebec, Canada; 4Downtown Women's Health Care, Denver, CO; 5Clinique RSF Inc., Quebec, Canada; 6Johns Hopkins Center for Sexual Health and Medicine, Lutherville, MD; 7St. Michael's Hospital Health Center, Toronto, Ontario, Canada; 8Phase II Center for Women's Health, Salt Lake City, UT; 9QUEST Research Institute, Southfield, MI; 10Betty Byrne Henderson Women's Health Research Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia; 11The Center for Marital and Sexual Health, Inc., Beachwood, OH; 12Procter and Gamble Pharmaceuticals, Mason, OH; and 13Women's Clinical Research, Seattle, WA.

Received November 22, 2005; revised and accepted February 7, 2006.

This study was funded by research grants from Procter & Gamble Pharmaceuticals, Mason, OH.

Address correspondence to: Jan L. Shifren, MD, Vincent Memorial Obstetrics and Gynecology Service, Department of Obstetrics and Gynecology, Massachusetts General Hospital, 55 Fruit Street, Yawkey 10A, Boston, MA 02114. E-mail: jshifren@partners.org.

©2006The North American Menopause Society