The FDA has approved a new oral contraceptive (Seasonale®, Barr Laboratories) for women. Seasonale® contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in traditional oral contraceptives.
Seasonale® offers a 91-day regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by one week (seven days) of placebo (inactive) tablets. Conventional oral contraceptive use is based on a 28-day regimen (21 days of active tablets, followed by seven days of placebo tablets).
Under the new dosing regimen, the number of expected menstrual periods usually experienced by women is reduced from once a month to about once every three months. As with the conventional 28-day regimen, women have a menstrual period while taking the placebo tablets.
Although Seasonale® users have fewer scheduled menstrual cycles, 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.
Some physicians have raised concerns about the consequences of long-term suppression of menstruation, suggesting that data are insufficient to prove that suppression is safe. They also noted that the women in the studies were already taking oral contraceptives and thus would “automatically” be able to tolerate the medication; they were not compared with a control group of women who were not taking oral contraceptives. The supporters of menstrual suppression argue that ovulation itself can inflame the lining of the ovary and might be linked to ovarian cancer. The debate, no doubt, will rage on.
Because Seasonale® users can expect to have fewer periods, the label also advises women to consider the possibility that they might be pregnant if they miss any scheduled periods.