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Intrinsa Sex Patch Shows Promise In Post-Menopausal Women

Posted by Chrissie Cole
Thursday, November 06, 2008 11:05 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Testosterone, Estrogen, Women's Health, Proctor & Gamble, Intrinsa Patch, Menopause, Breast Cancer

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IMAGE SOURCE:© Wikimedia Commons / Venus / author: Kyle

A female testosterone patch showed promising results in boosting the enjoyment of sex in post-menopausal women, but preexisting concerns about the cancer risk of hormone therapies means U.S. women won’t be getting an comparable Viagra anytime in the near future.

Since 1999, Proctor & Gamble (P&G) has been working to gain U.S. approval for its Intrinsa patch, intended to increase sex drive and satisfaction in women after menopause.

A new company-run study of the patch, delivers a constant stream of testosterone, a hormone linked with sex drive in both men and women, is published in the November 6 issue of The New England Journal of Medicine.

Intrinsa, currently available in Europe, is designed to treat hypoactive sexual desire disorder.” In simpler terms, it means a lack of interest in sex that leads to unhappiness.

For the study, women with an average age of 54 were asked to track their sexual episodes in a weekly diary and note which ones they considered “satisfying.” The women were split in two groups – 264 women wore Intrinsa patches, changed twice a week and 277 women wore a placebo.

Before using the patches, the women in the study reported a 2.5 average of satisfying sexual episodes per month. After six months, women wearing the patch reported 4.6 satisfying episodes, compared with 3.2 in the group of women wearing a fake patch.

Three of the 264 participants with the patch developed breast cancer, compared with none on the placebo patch. A women in a third group – taking a low-dose version of the patch – developed breast cancer.

While the findings are not statistically significant, they support fears that long-term hormone therapy may lead to breast cancer in women.

The Women’s Health Initiative (WHI), sponsored by the U.S. government was designed to examine health issues in postmenopausal women. In 2002, it was discontinued after researchers found that HRT increased the risk of adverse events including blood clots, heart attack and breast cancer.

The risk was based on whether the woman was taking estrogen independently or with progesterone, another female hormone, not testosterone – but it has led to dramatic changes in the treatment of post-menopausal women and much caution about hormone therapies by the FDA.

Those findings hindered Proctor & Gamble’s attempt to convince an FDA advisory panel that Intrinsa was safe.

The breast-cancer cases associated with this week’s report were too small to establish “evidence that Inrinsa increases the risk of breast cancer,” said Millikin. Two of the three women may already have had breast cancer before starting on the patch, the study said.

Another study found women taking hormone replacement therapy, or HRT, to treat menopause symptoms are not at an increased risk of heart attack, especially if using cream, skin patch or taking “cyclic” hormone combinations, reports Danish researchers. #


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