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Sunday, Nov 8, 2009
A new FDA-approved birth control pill will give women just four periods per year. But is it safe to stanch the flow?
Nov 25, 2003 | Menstruation never suited Angela Fontaine. Between swimming, fishing, skiing, raising a 9-year-old daughter, and working 12-hour shifts as a labor and delivery nurse, there wasn't enough time to waste a few days each month feeling bloated and cranky. So when the 29-year-old from Jacksonville, Fla., learned she could do away with her periods -- or at least most of them -- she jumped at the chance.
The opportunity came in the form of a clinical trial for a new type of birth control pill called Seasonale. Released this month by Barr Laboratories, Seasonale -- which gives women just four periods per year -- is the first FDA-approved birth control pill designed to overhaul the time-honored monthly cycle. While the FDA and much of the medical community have already signed off on other period-suppressing contraceptive methods -- such as the injection known as Depo-Provera and the slow-release hormonal implant called Norplant, both of which cause irregular menstruation in some users, or stop it entirely -- the advent of Seasonale promises a newly predictable way of cutting down on periods.
Like traditional birth control pills, Seasonale contains synthetic estrogen and progesterone. And like the traditional pills, the new drug runs about a dollar per pill. The difference is that with Seasonale, women will take 84 days of the hormones -- as opposed to 21 -- before starting their seven-day course of placebos, and they will get their periods just once every three months.
"I felt much better on it, and I didn't have any side effects," says Fontaine. Now through with the yearlong trial, which included 682 women, and temporarily off the pill to try to conceive, she says that once her next child is born, she'll never go back to monthly menstruation.
Fontaine is far from alone. According to a study by the market research firm RoperASW, two-thirds of women say they would happily forgo menstruation if the method were safe. And their dreams may soon be realized, as many experts expect the next step will be a pill designed to do away with the period altogether. Indeed, some women are too eager to wait for a new drug. In recent years, more and more women have been opting out of their periods -- some on the advice of doctors who recommend menstrual suppression to relieve painful periods, and others who simply prefer to avoid the monthly hassle -- by taking regular birth control pills nonstop and skipping the seven days of placebos that come in each pack.
Now, as Barr Laboratories gets ready to unleash a 250-person sales force to market its new drug to healthcare providers around the country, menstrual suppression is going mainstream. And as it does, questions are mounting: Is it safe, or are women endangering their health for the sake of convenience? Is the monthly cycle a woman's natural rhythm, best left alone, or is it an arbitrary medical construct? Are periods a central component of female identity, or are they merely an impediment -- as treatable as bad eyesight?
According to Dr. Leslie Miller, an assistant professor of obstetrics and gynecology at the University of Washington who advocates menstrual suppression by the taking of continuous low-dose birth control pills, the uterus was simply not designed to bleed every month. Historically, says Miller, who has suppressed her own period for years, women started menstruating later in their lives, and then spent many years pregnant and breast-feeding. "One hundred years ago, the average woman had fewer than 50 periods during her life," Miller writes on her menstrual suppression Web site. "Now, the modern woman could have 450 lifetime periods."
Miller also points out that the periods women have on the traditional birth control pill hardly constitute true menstruation. "It's a fake period," she says, noting that the bleeding that happens on the pill has nothing to do with ovulation. Women on the pill only bleed each month because the placebos cause their hormones to change and their uterine lining to weaken.
In fact, when the pill was first developed in the 1950s, its inventors acknowledged that women taking the drug did not need to have periods every month. "In view of the ability of this compound to prevent menstrual bleeding as long as it is taken," wrote one of the pill's original developers in 1958, "a cycle of any desired length could be produced." The pill's makers settled on a monthly cycle -- 21 days of hormones, followed by seven days of placebos -- to mimic a woman's natural cycle. It was a decision guided more by public relations than medical science. If the pill produced a monthly cycle, they figured, women would be more comfortable taking the drug.
Still, not everyone is convinced that the era of the period is coming to an end. Susan Rako, a Boston psychiatrist and the author of "No More Periods? The Risks of Menstrual Suppression and Other Cutting-Edge Issues About Hormones and Women's Health," calls menstrual suppression "the largest uncontrolled experiment in medical history." Rako says that women who eliminate their periods can develop symptoms of testosterone deficiency, such as diminished sexual desire, loss of muscle tone, reduced energy, and weight gain.
