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Freedom from the Menstrual Cycle?

By Amy Tsao Most reproductive-health experts support a notion that may seem radical: A woman's monthly period could soon become a thing of the past. "Many women have challenging and difficult lives, and can't be bothered with menstruation. There's no reason for women not to avoid their period if they like," says David Grimes, clinical professor at the University of Northern California School of Medicine.

Indeed, the rationale is strong for doing away with monthly periods. They're essentially a modern phenomenon, anyway. Historically, women of childbearing age were either pregnant or breast-feeding children most of the time. Between nine months of gestation, 20 months of nursing, and often-successive pregnancies, many women in the past had relatively few periods.

Monthly periods as we know them now can actually lead to negative health effects, including anemia and cramps, says Sheldon Segal, an endocrinologist with the Population Council, a nonprofit research group and co-author of Is Menstruation Obsolete? (Oxford University Press, 1999).

NEW REGIMEN. Now, American women may soon have the option of nearly eliminating their periods if they want by using a new version of the birth-control pill. If approved sometime in 2003, as expected, Barr Laboratories' (BRL) Seasonale will become the first pill to be marketed as a continuous regimen in the U.S.

Women using the drug, a combination of two existing birth-control treatments comprising the hormones estrogen and progestin, would get a period just four times a year, instead of 13. Women in Australia and Europe are now experimenting with such a regimen.

In the U.S., the birth-control pill as now approved works on a 28-day cycle. It suppresses the process of ovulation, in which an egg is released from an ovary so it can be fertilized. For 21 days, patients take active pills that trick the body into thinking it's ovulating. Then, for seven days, the pills contain only sugar, and the woman has a period as her hormone levels drop.

MAJOR IMPLICATIONS. With Seasonale, women would be on a 91-day cycle, taking active pills for 84 days and sugar pills for one week. Barr spokesperson Carol Cox says the company figured four periods annually would be "a frequency that women would be interested in." And it could have important career and lifestyle implications for many women, both in the home and workplace.

A one-year trial of 1,376 patients was recently completed, and results so far show that Seasonale was as effective at preventing pregnancy as conventional birth-control methods. The most significant negative side effect is that patients taking Seasonale had more incidences of breakthrough bleeding, or bleeding between cycles. But the incidents typically occurred early on and decreased over time, says Freedholf Anderson of Eastern Virginia Medical School, the lead investigator for the Seasonale trial. Other side effects, like nausea, headaches, and bloating, were similar to existing birth-control pills.

A green light for Seasonale could have repercussions for how the pill -- the most popular form of birth control used by women -- is taken in general. If doctors are comfortable that Seasonale is safe and effective, many women who are already taking the pill may switch to a period-free regimen by simply taking their existing drug all month long without stopping.

CULTURAL CONDITIONING? However, Seasonale's popularity ultimately will depend on women abandoning a deeply engrained belief -- that a monthly period is "natural" and somehow necessary. "It's a cultural change for women really, and will be somewhat gradual," says Geoffrey Redmond, endocrinologist at the Hormone Center in New York. Still, notes David Moskowitz, analyst with Friedman, Billings Ramsey: "Women are used to taking the pill. I don't see too many barriers there."

Barr Labs expects the product to get about 5% of the $2 billion oral-contraceptive market, or $100 million in sales, a few years after approval. For giants like Johnson & Johnson (JNJ) and Wyeth (WYE), the two biggest producers of oral contraceptives, such revenue potential would be small potatoes. J&J sold $1 billion worth of oral contraceptives in 2001.

However, it would be a major product for Barr, which had total 2001 sales of only $510 million. A top generic-drug maker with a specialty in women's health, Barr has seen its shares drop from a 52-week high of $90 to around $70 lately.

SEEKING MORE DATA.Of course, women who chose can take current birth-control pills on a continuous basis and achieve similar results. Such treatment has been widely advised for years to help women who experience severe pain from their period. Women athletes also have been known to use the pill continuously to suppress their periods. Other contraceptive methods, including intrauterine devices and sterilization, can also eliminate or greatly reduce the number of times a woman gets her period.

Barr plans another year of study to get more detailed data on Seasonale patients. Researchers stress that additional studies may be required to prove that this kind of continuous dosing is safe over the long term. But so far, indications are that going longer between periods won't cause women any serious problems.

Rivals are working on new formulations of birth control for women like hormone patches and vaginal rings, but Barr is the only one seeking approval for a continuous birth-control regimen. J&J's Ortho-McNeil division would not comment on its plans for studying continuous dosing with its birth-control pills. However, spokesperson Kellie McLaughlin says "it is an area with a lot of interest in it."

Insurance companies will have to buy into continuous dosing for the trend to really take off. But women who want the option are likely to apply pressure there. The potential productivity gains from fewer workdays lost to cramps could be compelling. Indeed, the impact of this new type of pill might someday be nearly as great as when the original pill was first introduced four decades ago. Tsao covers biotech and pharmaceutical issues for BusinessWeek Online

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