Is there a place for testosterone replacement?

Arch Intern Med. 2005 Jul 25;165(14):1582-9.

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

Braunstein GD,Sundwall DA,Katz M,Shifren JL,Buster JE,Simon JA,Bachman G,Aguirre OA,Lucas JD,Rodenberg C,Buch A,Watts NB.

Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif, 90048, USA. Glenn.Braunstein@cshs.org

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 microg/d (n = 107), 300 microg/d (n = 110), or 450 microg/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-microg/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-microg/d group showed no evidence of a treatment effect. The 450-microg/d group also was not statistically different from the 300-microg/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-microg/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.

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