TRENTON, N.J. (AP) – Women looking for a simple way to avoid their menstrual period could soon have access to the first birth control pill designed to let women suppress monthly bleeding indefinitely.
The U.S. Food and Drug Administration is expect to announce approval Tuesday for Lybrel, a drug from Wyeth which would be the first pill to be taken continuously.
Lybrel, a name meant to evoke “liberty,” would be the fourth new oral contraceptive that doesn’t follow the standard schedule of 21 daily active pills, followed by seven sugar pills – a design meant to mimic a woman’s monthly cycle. Among the others, Yaz and Loestrin 24 shorten monthly periods to three days or less and Seasonique, an updated version of Seasonale, reduces them to four times a year.
Gynecologists say they’ve been seeing a slow but steady increase in women asking how to limit and even stop monthly bleeding. Surveys have found up to half of women would prefer not to have any periods, most would prefer them less often and a majority of doctors have prescribed contraception to prevent periods.
“I think it’s the beginning of it being very common,” said Dr. Leslie Miller, a University of Washington-Seattle obstetrician-gynecologist who runs a Web site focused on suppressing periods. “Lybrel says, ‘You don’t need a period.”‘
While that can be done easily – sometimes more cheaply – by skipping the sugar pills or replacing birth-control patches or vaginal rings sooner, doctors say the trend is fueled mainly by advertising for the new options.
Sheldon J. Segal, a scientist at the nonprofit research group Population Council, wrote back that a British study found no harm in taking pills with much higher hormone levels than today’s products for up to 10 years.
“Nothing has come up to indicate any unexpected side effects,” said Segal, who co-authored the book “Is Menstruation Obsolete?”
Most doctors say there’s no medical reason women need monthly bleeding and that it triggers health problems from anemia to epilepsy in many women.
‘They note women have been tinkering with nature since the advent of birth control pills and now endure as many as 450 periods, compared with 50 or so in the days when women spent most of their fertile years pregnant or breast-feeding.
Barr Pharmaceuticals of Woodcliff Lake, N.J., whose subsidiary Duramed already is developing a lower-estrogen version of Seasonique, said its research with consumers and health care providers indicates they feel four periods a year is optimal, said a spokeswoman.
Niemann.
Wyeth obviously thinks otherwise.
“It allows women to put their menstrual cycle on hold” and reduces 17 related symptoms, from irritability to bloating, based on one small study, said Dr. Amy Marren, director of clinical affairs for Wyeth Pharmaceuticals.
Marren said Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel.
That might cause too much breakthrough bleeding, already a problem with some newer pills with low hormone doses, said Dr. Lee Shulman, a Chicago obstetrician-gynecologist who chairs the board of the Association of Reproductive Health Professionals.
In testing of Lybrel, 59 percent of women ended up with no bleeding after six months, but 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth.
“You’re now basically trading scheduled bleeding for unscheduled bleeding, and I don’t know whether American women will buy into that,” Shulman said.
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On the Net:
www.wyeth.com
Association of Reproductive Health Professionals menstruation site: www.arhp.org/healthcareproviders/resources/menstruationresources
Dr. Miller’s Web site: www.noperiod.com
AP-ES-05-18-07 1956EDT
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