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The arrival on the European market of a female-targeted testosterone patch to treat low sex desire caused by menopause is raising new questions in the United States about why there is no equivalent product on pharmacy shelves. Opponents say that there is good reason why, and the patch is not ready for U.S. approval.
The European Medicines Agency -- the European Union's equivalent of the U.S. Food and Drug Administration -- approved sales of Procter and Gamble's Intrinsa testosterone patch last year, and it went on sale this spring. The patch is intended for women distressed by low sexual desire after surgical removal of their ovaries and uterus.
Three years ago, the FDA turned down Procter and Gamble's application for U.S. approval of Intrinsa because of inadequate safety data while also concluding that it was effective. Instead U.S. women who want testosterone rely on products for men or creams specially mixed by pharmacists.
Cincinnati-based Procter and Gamble estimates that 15 to 20 percent of prescriptions written for men's testosterone products are used by women.
About 621,000 U.S. women a year undergo hysterectomies, more than any other country, most often to remove uterine fibroids (benign tumors) or because of endometriosis, which causes tissue to grow outside the uterine lining. Of U.S. women alive today, 22 million have undergone a hysterectomy and about 75 percent lost their ovaries along with their wombs.
Removal of the ovaries means plunging immediately into menopause. These women, plus those in natural menopause, represent a potential testosterone market of billions of dollars. By age 60, 1 in 3 U.S. women will have had a hysterectomy.
Testosterone in women, as in men, stimulates sexual desire and affects the level of sexual pleasure besides contributing to muscle and bone mass and general good health. Half a woman's testosterone is lost if her ovaries are removed (the other half is produced by the adrenal glands); natural menopause gradually decreases testosterone levels by one-third. Estrogen supplements suppress the effects of the remaining testosterone, a side effect that has long been downplayed.
'Medicalization of Menopause'
The testosterone patch is now for sale in England, Germany, France and Italy, but
Leonore Tiefer, a critic of what she calls the "medicalization of sexual desire and menopause" opposes the product. She and other critics believe that the six-month clinical trials conducted by Procter and Gamble are "inadequate to assess the risks of extended" treatment.
A sex therapist and clinical associate professor of psychiatry at New York University, Tiefer relies on education and counseling to help women improve their sexual desire and experiences. A member of FDA advisory committees that recommend approval or rejection of new drugs, Tiefer described the European approval process as less stringent than the FDA's.
Because there are no long-term safety studies, the European drug agency has required Procter and Gamble to label Intrinsa with a special warning to that effect, and is monitoring use of the hormone.
Testosterone supplements for women are controversial not only because of safety questions but also because sexual desire in women results from a complex mix of physical, social and emotional factors.
Barbara Bartlik, a psychiatrist and sex therapist at Weill-Cornell Medical Center in New York, said she is eager to see the patch approved for the United States. "When patients who are low in testosterone get supplemented, there's a world of difference. They have a spark of interest back." That, she said, can encourage women to work on other problems, such as relationship difficulties, that might be interfering with their sex lives.
Testosterone also makes arousal and orgasm easier to achieve and more satisfying, Bartlik said. She prescribes a trial of testosterone cream that is compounded to order by pharmacists.
Not the 'Pink Viagra'
See more stories tagged with: intrinsa, testosterone, hysterectomies, procter and gamble, fda, viagra, sex drive, orgasm
Author and journalist Frances Cerra Whittelsey writes about consumer and women's issues and the environment from her home in Huntington Bay, Long Island. She has previously written about testosterone deficiency in the context of women's cancer treatment.
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