Safety and Efficacy of a Testosterone Patch for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Top Cited Papers
- 25 July 2005
- journal article
- clinical trial
- Published by American Medical Association (AMA) in Archives of internal medicine (1960)
- Vol. 165 (14) , 1582-9
- https://doi.org/10.1001/archinte.165.14.1582
Abstract
Background: Oophorectomy reduces serum testoster- one levels. We studied the efficacy and safety of trans- dermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women. Methods: A 24-week, randomized, double-blind, pla- cebo-controlled,parallel-group,multicentertrialwascon- ducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo- oophorectomy and hysterectomy and who were receiv- ing oral estrogen therapy. Women were randomized to receive placebo (n=119) or testosterone patches in dos- agesof150µg/d(n=107),300µg/d(n=110),or450µg/d (n=111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary ef- ficacy outcome measures. Results:Ofthe447womenrandomized,318(71%)com- pleted the trial. Compared with placebo, women receiv- ing the 300-µg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P=.05) and in frequency of satisfying sexual activ- ity (79% vs 43%; P=.049). The 150-µg/d group showed no evidence of a treatment effect. The 450-µg/d group also was not statistically different from the 300-µg/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 fre- quency in both groups; no serious safety concerns were observed.Keywords
This publication has 1 reference indexed in Scilit:
- Psychological Reactions and Sexual Life after Hysterectomy with and without OophorectomyGynecologic and Obstetric Investigation, 1992