New Pill, Fewer Periods

Last Editorial Review: 9/9/2003

A new "extended-cycle" birth control pill called Seasonale has been approved by the Food and Drug Administration. Like traditional oral contraceptives, Seasonale contains estrogen and progestin. What is different is the dosing schedule. By "extended cycle" it means that women using Seasonale will only have 4 menstrual cycles a year as compared to 13.

Plus: Seasonale prevents pregnancy and is as safe as traditional birth-control pills.

Minus: Women on Seasonale had more bleeding and spotting during the three months between periods.

Comment: Opponents of Seasonale include those who advocate menstruation as a necessary monthly shedding of the uterine lining. They question whether it is healthy to alter the natural schedule of menstruation. And then there is the biblical belief that menstruation was a curse inflicted on Eve because of the original sin to be passed along to all women thereafter.

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Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors,

FDA Approves Seasonale Oral Contraceptive

The FDA has approved Seasonale, a new choice in oral contraceptives for women for prevention of pregnancy. Seasonale is a 91-day oral contraceptive regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by one week (7 days) of placebo (inactive) tablets. Conventional oral contraceptive use is based on a 28-day regimen (21 days of active tablets followed by 7 days of placebo tablets). Seasonale contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in already approved oral contraceptives.

Under Seasonale's dosing regimen the number of expected menstrual periods that a woman usually experiences are reduced from once a month to about once every three months. As with the conventional 28-day regimen, women will have their period while taking the placebo tablets.

Although Seasonale users have fewer scheduled menstrual cycles, the data from clinical trials show that many women, especially in the first few cycles of use, had more unplanned bleeding and spotting between the expected menstrual periods than women taking a conventional 28-day cycle oral contraceptive.

Like other available oral contraceptives, Seasonale is effective for prevention of pregnancy when used as directed. The risks of using Seasonale are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination estrogen and progestin containing contraceptives. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Since Seasonale users can expect to have fewer periods, the label also advises women to consider the possibility that they may be pregnant if they miss any scheduled periods. Women should discuss contraceptive use and the precautions and warnings for use of the drug with their doctors.

Seasonale is manufactured by Barr Laboratories of Pomona, New York.

Source: FDA Talk Paper # T03-65, September 5, 2003


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