(WOMENSENEWS)--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'
Some media reports have called the patch the new "pink Viagra," but the company's studies have shown that to be a misnomer. In contrast to Viagra, which can take effect in minutes, testosterone patch users take weeks before experiencing an uptick in sexual interest.
Two clinical trials conducted by Procter and Gamble involving about 1,000 women over six months also found that Intrinsa's libido effect was fairly subtle, with users reporting one more sexual experience per week than before enrolling in the trial.
Of great interest to critics like Tiefer is the limited quantitative sexual benefit for patch users, who reported just one additional satisfying sexual experience a month than those who received a placebo patch. Both groups were also helped by discussing their sexual problems with physicians and often their partners.
Concerns over the safety of Intrinsa linger, especially in light of the negative findings of the U.S. government's Women's Health Initiative in regard to estrogen supplements. The women in the testosterone trials were also receiving estrogen.
Dr. Johna Lucas, medical director for women's health at Procter and Gamble, said the safety data submitted in the approved application to the European Medicines Agency did not differ "materially" from the information provided to the FDA.
A spokesperson for the company declined to say whether the company has renewed its FDA application for approval.
Women's health advocates are adamant that longer-term studies are needed before another hormone is approved for use.
"We'd be delighted if they (Procter and Gamble) would come back with information about the testosterone patch that defined the risks," said Cindy Pearson, executive director of the National Women's Health Network, a nonprofit in Washington, D.C. "Define the risks, that's all we're asking for."
Hysterectomies Supply Drug Market
Nora Coffey, is founder of the Philadelphia-based Hysterectomy Educational Resources and Services Foundation, which provides public education about the surgery. She would like to limit the testosterone market by eliminating almost all hysterectomies because removal of the uterus and ovaries is the equivalent of male castration. She believes hysterectomies should be performed only on women with life-threatening problems and not for symptoms like excessive menstrual bleeding.
Seventy-five percent of 930 hysterectomized women who completed a questionnaire for the foundation reported "diminished or absent sexual desire" and nearly 60 percent reported "diminished or absent orgasm."
"So what if you could take something (testosterone) that made you desire sex," said Coffey, "but then what? You will not experience the uterus and pelvis filling with blood and the uterine contractions that occur during orgasm."
In July, the Journal of Sexual Medicine published an "add-on study" to Procter and Gamble's original clinical trials of Intrinsa.
According to the study's lead author Sheryl Kingsberg, slightly more than half the women said the increase in sexual activity of one experience per week was meaningful and beneficial. Eighty percent said they would like to continue treatment. Not every patch user responded to the treatment, and those who did not said they would not want to continue. The study was financed by Procter and Gamble.
Kingsberg believes the FDA should approve the patch. "We seem to have a different standard for tolerating risk-benefit for women than men, and risk-benefit for anything related to women's sexuality," she said. "Women's sexuality is considered almost a life-style choice rather than a health issue. Certainly the women thrown into menopause very young and even women who go into menopause in their 50s, they are not so ready to give up on their sexual lives."
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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For more information:
Leonore Tiefer's New View Campaign, Challenging the Medicalization of Sex:
Susan Rako Web site with testosterone deficiency symptoms:
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