Norm Mazer, MD, PhD, senior medical research fellow at Watson Labs and the study's designer, says, "This study was built on the work of earlier researchers who first recognized the potential of testosterone to improve sexual functioning in women after surgical menopause. But these earlier studies treated women with testosterone injections or implants, which resulted in higher than normal serum testosterone levels. The testosterone patches developed by Watson Laboratories were specifically designed to restore testosterone levels to the normal range of healthy young women."
The research team enrolled 75 women, ages 31 to 56, who had undergone hysterectomy and oophorectomy (surgical removal of the ovaries) from one to 10 years before the study began. Prior to treatment all participants had testosterone levels that were below average in comparison to healthy young women, and despite daily oral estrogen replacement therapy, all reported having less active or less satisfying sex lives as compared with before their surgery.
During the 36-week study, the women went through three consecutive 12-week treatment periods during which they received, in random order, three combinations of skin patches. The patches delivered daily doses of either 300 micrograms of testosterone, 150 micrograms of testosterone, or a placebo. Neither the participants nor the investigators working with them knew which patch combinations the women were receiving at any time. The women completed an evaluation of sexual functioning - including desire, arousal, activity and pleasure - as well as an evaluation of overall psychological well being, at the beginning of the study and at the end of each treatment period. Testosterone levels were measured at four-week intervals, and the participants continued to receive oral estrogen replacement therapy throughout the study.
Data sufficient for
'"/>
Contact: Susan McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
6-Sep-2000