Dosing menopausal women with testosterone may be the key to helping those with low libidos get back in the mood, according to a new study. Proctor & Gamble Pharmaceuticals has published the results of a new trial of their testosterone patch, called Intrinsa, and say the results are encouraging for frustrated older women seeking a “Viagra for women.” However, nagging safety concerns are likely to keep the drug off the market in the United States for some time to come (although the drug is already on sale in Europe): During the new study, four of the test subjects using the patch developed breast cancer.
The 52-week study included 814 women with sexual desire disorder, characterized by troublesome low sexual desire or function…. The women were asked to keep sexual encounter diaries, and researchers used other established measures to assess sexual response during the six-month evaluation phase of the study. They found that compared to placebo users, the women who used the 300 microgram patch reported significant improvements in sexual functioning, including desire, arousal, orgasm, and pleasure [WebMD].
Lead researcher Susan Davis says the study, just published in the New England Journal of Medicine [subscription required], was overwhelmed with volunteers. All of the women — in the United States, Canada, Australia and Britain — had reported a decrease in sex drive after menopause, which was either natural or surgically induced. “What they say is, ‘I’m too young to start feeling like this. I have a lot of years ahead in my relationship. This is important to me,’” said Davis [Reuters].
Proctor & Gamble is eager to get the drug approved for the U.S. market, but the Food and Drug Administration has been wary of such hormone treatments. The agency has … told manufacturers it will require a large “safety” study, likely with several thousand patients, before approving testosterone products to increase women’s sex drives [The Wall Street Journal]. Proctor & Gamble has argued that such drugs don’t pose a cancer risk; the company says the four breast cancer cases in the new study aren’t statistically significant, and also says that two of the women may have had breast cancer before they enrolled in the study.
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