Women who are inconvenienced by having 13 periods a year can reduce the number to four by taking a new birth control pill.
The pill, called Seasonale, received approval by the Food and Drug Administration on Sept. 5.
Seasonale, which was developed by Barr Laboratories in an agreement with Easter Virginia Medical School, is the first of its kind to receive FDA approval and is expected to be available by prescription at the end of October 2003.
Seasonale consists of 84 active pills, containing the hormones estrogen and progestin, followed by seven inactive tablets. In comparison, traditional oral contraceptive regimens consist of 21 active pills and seven inactive.
“With today’s approval of Seasonale, women have a new choice when deciding on oral contraception,” Carole S. Ben-Mainom, M.D., president and COO of Barr Research, said in a press release. “For those women who prefer the convenience of fewer periods, Seasonale offers a safe and effective alternative to the traditional 28-day oral contraceptive regimen.”
Birth control pills were first approved in the U.S. in 1960 and are now the most popular form of reversible birth control in the country, according to the FDA. When taken correctly, oral contraceptives are more than 99 percent effective in preventing pregnancy.
The pill was originally designed to mimic a woman’s menstrual cycle by allowing her to have a period every four weeks. Recent research, however, suggests that there is no medical need for women to menstruate every month.
Some women also take the pill for non-contraceptive purposes. In addition to regulating one’s periods and lessening cramps, taking an oral contraceptive can also decrease the occurrence of ovarian cysts, ectopic pregnancies and uterine and ovarian cancers, according to www.knowyourperiod.com.
In a clinical trial, side effects from Seasonale were comparable to those of other birth control pills. The most common include cold symptoms, headaches and spotting or light bleeding between periods.
“For some women during the first couple of cycles there was a higher occurrence of spotting,” said Barr Spokeswoman Carol Cox. By the end of the yearlong trial the frequency of spotting was equal to that of traditional oral contraceptives, Cox said.
Heather Musgrove, a sophomore biology major, is impressed by the approval of Seasonale, but is concerned about any potential long-term side effects.
“The only thing I would wonder about is how, in the long run, it would affect your cycle,” she said.
The long-term effects of taking an extended-cycle contraceptive remain to be seen, though the women participating in the study have not yet experienced any adverse effects, Cox said.
Overall, Cox said the appeal of Seasonale is its convenience.
“I think it just offers (women) another choice,” Cox said. “Women who’ve already decided they want to take an oral contraceptive now have the option to reduce their periods to four times a year.”
In a recent Roper survey, 63 percent of women ages 18-24 said they would be interested in reducing the number of periods they experience each year.
Musgrove agreed that Seasonale would be much more convenient than the 28-day regimen.
“It’d be nice to not have to worry about your period every month,” she said. “It can get in the way and it’s a pain in the butt.”
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* The pill was first approved in the U.S. in 1960
* There is only one type of drug so well-known that it’s called “the pill”
* An estimated 100 million women have used the pill
* For the last 40 years, more people have taken the pill than any other prescribed medicine in the world.
* Japan was the last industrialized nation to legalize the pill in 1999
The press release included a photo of the product. It’s in the big blue folder on Kyle’s desk.