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Patch Matches Pill in Preventing Pregnancy

Weekly use could mean better compliance

TUESDAY, May 8 (HealthScout) -- Women looking for an alternative to oral birth control may soon be able to use a skin patch to avoid pregnancy.

A new study finds the hormone-secreting patch is 99 percent effective, the same as the pill at preventing conception. Yet a patch is far easier to use faithfully and that likely will lead to fewer accidental pregnancies, experts say.

Though no birth-control patch is yet available in the United States, the R.W. Johnson Pharmaceutical Research Institute of New Jersey is seeking Food and Drug Administration approval for its transdermal patch, called Ortho Evra. The institute funded the study.

The birth-control patch is a potent mimic of the hormone replacement patches already available to postmenopausal women. Affixed by adhesive, the 3.2-square-inch pad can be worn on the arm, buttocks or torso, though not on the breast.

The patches release a steady stream of estrogen and progestin for a week, blocking ovulation, creating an unfriendly atmosphere for sperm and discouraging implantation of a fertilized egg. Women must replace the pad only three times a month, whereas oral contraception requires 28 pills during each menstrual cycle.

The study, reported in the May 9 issue of the Journal of the American Medical Association, compared failure and compliance rates of the patch and the pill in 1,417 American and Canadian women, ages 18 to 45. The women were followed for either six or 13 menstrual cycles.

Women had perfect compliance with the pill in 77 percent of their monthly cycles, compared with 88 percent for the patch. Fewer than 5 percent of patches detached partly (2.8 percent) or completely (1.8 percent) before needing replacement.

Side effects from the patch were more common than from the pill, and included site reactions, breast pain and tenderness, and discomfort around the time of menstruation. These were generally mild and well-tolerated, the researchers say.

"I don't think you're going to see women stopping using this product because of its side effect profile any more than when they use birth control pills," says study co-author Dr. William Koltun, director of the Medical Center for Women's Clinical Research in San Diego.

While oral contraceptives are in theory extremely effective, they're quite sensitive to proper use. A 1995 survey found that compliance failure rates in the first year for women on the pill ranged between 7.3 percent and 8.5 percent, Koltun says. "I think [compliance] is a bigger issue than we talk about, and this particular product is going to" improve it, he says of the patch.

"Women are busy today, and having to worry about taking a daily pill has been taken for granted. This is a first attempt at making inroads in giving women some freedom," Koltun says. Larger studies of the patch may show that it is even more effective than the pill because of its improved compliance, he says.

Dr. Regine Sitruk-Ware, executive director for contraceptive development at the Population Council, a New York-based reproductive rights group, says the patch will never replace the pill, which has more than 12 million users in the United States and 100 million globally. But the fact that women don't have to worry about taking a drug every day will likely be a strong draw, she says.

While its immediate impact will likely be small, after a few years on the market Sitruk-Ware says between 10 percent and 15 percent of women who use birth control will be applying the patch.

This study was funded by R.W. Johnson.

What To Do

Dr. Paul Blumenthal, a Johns Hopkins University gynecologist and medical director of Planned Parenthood of Maryland, says the latest findings reveal "another promising method that will help meet the contraceptive needs of American women and women worldwide."

But, he says women shouldn't have overblown expectations. "There is no perfect contraceptive for every woman. They all have various advantages and disadvantages." One potential disadvantage of the patch is its size; it will take up a lot of real estate on a woman's body, he says.

Deciding what birth control is best for you is a little like settling into a career, Blumenthal says. "In the old days people had one job and they stuck with it." Now, he says, "I think that for a variety of reasons women may try a variety of methods, looking for one that best meets their needs," before they find one that's comfortable.

For more on contraception, visit Planned Parenthood. You can also try the Alan Guttmacher Institute.

Read more about contraceptives from HealthScout.

SOURCES: Interviews with William Koltun, M.D., director, Medical Center for Women's Clinical Research, San Diego; Regine Sitruk-Ware, M.D., executive director, contraceptive development, Population Council, New York City, and Paul Blumenthal, M.D., associate professor of obstetrics and gynecology, Johns Hopkins University School of Medicine, Baltimore, and medical director, Planned Parenthood of Maryland; May 9, 2001 Journal of the American Medical Association
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