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Kaiser Daily Women's Health Policy
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Contraception & Family Planning | Companies Testing Male Hormonal Contraceptives in Human Clinical Trials; FDA Approval Not Likely for Five Years
[Aug 04, 2004]

      Several hormonal contraceptive products for men are moving into later stage human clinical testing, meaning that "a safe and convenient 'male pill' ... may finally be on a path toward the medicine cabinet," the Wall Street Journal reports. A Phase III study -- the last stage of testing before a company can apply to FDA for approval -- of a hormonal contraceptive that reduces men's sperm count is set to begin in late 2005 in the United States, and researchers at the University of Washington in Seattle have begun enrolling men for a study of a product that uses a different hormone to lowers sperm count, according to the Journal. The products, which are administered through injections and implants, instruct the brain to stop making sperm in the testes. Side effects of the contraceptives -- some of which must be accompanied by testosterone injections -- can include acne, sweating, mood swings, an increase or decrease in libido and a gain in muscle mass. FDA approval of a male hormonal contraceptive is not expected for at least five years, according to the Journal.

Gaining Acceptance
Drug companies showed little interest in developing male hormonal contraceptives until a few years ago, when developments in testosterone replacement and sperm production cessation "prompted them to take another look," the Journal reports. Companies now believe "they can secure a return on their investment," William Bremner, a researcher and chair of the University of Washington's Department of Medicine, said. In addition, the concept of male-controlled contraception has become more acceptable among men. Currently, men account for one-third of all contraceptive use, primarily through condom use and vasectomies, according to the Journal. Men also have become more comfortable discussing sexual health, following the widespread promotion of condom use in the 1990s and erectile dysfunction drugs more recently, according to John Amory, an assistant professor of medicine who is involved with the University of Washington clinical trials, the Journal reports. However, others believe that women will retain the primary responsibility for contraception, according to the Journal. "Women are always going to use pills better than men would," Malcolm Potts, a public health professor at the University of California-Berkeley, said, adding, "Now, we have a strange political correctness -- that because women have a pill, men should have a pill -- and I think it's flawed" (Efrati, Wall Street Journal, 8/3).

For current women's health policy news, visit the National Partnership for Women & Families' website.


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