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| |  ENDO 99: Testosterone Patch Effective For Diminished Sexual Function In Surgically Menopausal Women SAN DIEGO, CA -- June 15, 1999 -- According to a soon-to-be-released study, an experimental testosterone patch offers new hope for women who suffer from diminished sexual function as a result of surgical menopause (removal of the ovaries and uterus). Glenn Braunstein, M.D., Chair of the Department of Medicine at Cedars Sinai Medical Center, presented the findings at the Endocrine Society Meeting in San Diego today (June 15). The study, which was conducted at nine U.S. Centers and involved 75 surgically menopausal women who suffered from diminished sexual function, found that the women experienced improvements in their sexual function and psychological well-being when small amounts of testosterone were administered with an experimental skin patch. The patch, which was used in combination with standard estrogen therapy, was an alcohol-free matrix patch that was applied to the abdomen and changed twice a week. This is the first-ever study conducted with a testosterone skin patch to treat sexual problems in surgically menopausal women, and these preliminary results indicate that transdermal testosterone is both beneficial and well tolerated in these women. Further, the study suggests that the small amounts of testosterone normally produced by a woman’s ovaries are important for maintaining sexual function and that loss of ovarian testosterone production can markedly diminish the quality of life for some women. During the study, each woman was treated for 12 weeks with two different doses of testosterone as well as with a placebo treatment, using combinations of active and inactive (placebo) patches. Estrogen replacement therapy was continued throughout the study. The women completed a questionnaire to assess their sexual function at the beginning of the study and at the end of the treatment period. They also completed a questionnaire that assessed their psychological well-being. The safety of the treatment was monitored for changes in laboratory values, facial and body hair growth, and acne. Hormone levels were measured periodically, and the skin was assessed to determine the local tolerability of the patches. Overall, the study showed that testosterone levels increased with the normal range in a dose-dependent manner and that estrogen levels did not change. There were improvements in sexual function and psychological well-being which were statistically significant for the higher dose of testosterone when compared to placebo. There was very little skin irritation observed, and there were only minimal effects on facial hair growth and acne. No adverse effects on the levels of cholesterol, glucose, insulin or on the frequence of hot flushes were observed. The research was funded by TheraTech, Inc., Salt Lake City and by Procter & Gamble Pharmaceuticals, Cincinnati, Ohio.
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