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

Full Abstract

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 microg/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 < or = 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 < or = 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.

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Author information

Author/s: Shifren, Jan L (JL); Davis, Susan R (SR); Moreau, Michele (M); Waldbaum, Arthur (A); Bouchard, Celine (C); DeRogatis, Leonard (L); Derzko, Christine (C); Bearnson, Patricia (P); Kakos, Norman (N); O'Neill, Sheila (S); Levine, Stephen (S); Wekselman, Kathryn (K); Buch, Akshay (A); Rodenberg, Cynthia (C); Kroll, Robin (R);

Affiliation: Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA 02114, USA. jshifren(-atsign-)partners.org

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Menopause (New York, N.Y.) (Menopause), published in United States. (Language: eng)

Reference: -2006 Sep-Oct; vol 13 (issue 5) : pp 770-9

Dates: Created 2006/09/21; Completed 2007/09/18;

PMID: 16932240, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

ErratumIn: Menopause. 2007 Jan-Feb;14(1):157.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Administration, Cutaneous
Adult
Aged
Androgens - administration & dosage; blood; therapeutic use
Double-Blind Method
Female
Humans

Humans
Menopause - physiology
Middle Aged
Sexual Behavior - drug effects
Sexual Dysfunctions, Psychological - drug therapy
Testosterone - administration & dosage; blood; therapeutic use
Treatment Outcome

Associated Chemicals: Androgens (0) ; Testosterone (58-22-0)

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