Is there a place for testosterone replacement?

Menopause. 2006 Sep-Oct;13(5):770-9.

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

Authors:

Shifren JL,Davis SR,Moreau M,Waldbaum A,Bouchard C,DeRogatis L,Derzko C,Bearnson P,Kakos N,O'Neill S,Levine S,Wekselman K,Buch A,Rodenberg C,Kroll R.

Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA 02114, USA. jshifren@partners.org

Objectives:

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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