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

Abstract

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.

• Authors: Glenn D Braunstein, Dale A Sundwall, Molly Katz, Jan L Shifren, John E Buster, James A Simon, Gloria Bachman, Oscar A Aguirre, Johna D Lucas, Cynthia Rodenberg, Akshay Buch, Nelson B Watts
• Journal: Archives of internal medicine (Arch Intern Med) Vol. 165 Issue 14 Pg. 1582-9 (Jul 25 2005) ISSN: 0003-9926 [Print] United States
• PMID: 16043675 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androgens
• Estrogens
• Gonadal Steroid Hormones
• Testosterone

Topics

• Administration, Cutaneous
• Adult
• Aged
• Androgens (administration & dosage)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Estrogens (therapeutic use)
• Female
• Gonadal Steroid Hormones (blood)
• Humans
• Hysterectomy
• Menopause, Premature (drug effects)
• Middle Aged
• Ovariectomy (adverse effects)
• Sexual Behavior (drug effects)
• Sexual Dysfunctions, Psychological (blood, drug therapy, etiology)
• Testosterone (administration & dosage, adverse effects)
• Treatment Outcome