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

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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

Author Information

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: [email protected].

Menopause 13(5):p 770-779, September 2006. | DOI: 10.1097/01.gme.0000243567.32828.99

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.

©2006The North American Menopause Society

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