SAN FRANCISCO — Seasonale and Seasonique are already on the market, and they will soon be joined by several other extended contraception options that will allow women to regulate their menstrual periods in a multiplicity of different ways, Dr. Carolyn L. Westhoff said at a conference on contraceptive technology sponsored by Contemporary Forums.
“From a medical point of view, there is no necessity to mimic regular cycling,” said Dr. Westhoff of Columbia University, New York. “Lots of women are happy with the 21/7 pill, … but it's like the Model T of birth control. You don't have to do it that way anymore.”
A continuous monophasic pill designed to be taken daily for 365 days is nearing Food and Drug Administration approval, she said. The pill's anticipated trade name is Lybrel.
And there are numerous other extended formulations in development. Beyond that, individual physicians and their patients are experimenting with the off-label use of options that are currently on the market.
“I would predict that we're not even going to see new pills with 21/7 [cycling] anymore,” Dr. Westhoff said. “I think every variation is reasonable, whether it's 2 months or 3 months or 4 months or 6 months, [depending on] what the patient might want. Or it could be a 3-month cycle once in a while. Those sorts of regimens probably aren't going to be FDA approved, because it's hard to go to the FDA with data to cover all those different flexible possibilities.”
Although a monthly cycle that repeats throughout a woman's adult life may seem normal, in fact contemporary women experience far more periods than their hunter-gatherer ancestors did. Calculations taking into account a later age of menarche, a younger age at first birth, a larger number of live births, and a longer period of breast-feeding suggest that a hunter-gatherer woman experienced approximately 160 menstrual periods in her lifetime. In contrast, contemporary women experience about 450.
Furthermore, there are many health advantages to medically regulating menstruation, including reductions in menorrhagia, uterine fibroids, adenomyosis, endometriosis, iron-deficiency anemia, and catamenial conditions such as migraine headaches and seizures.
On the other side, there's little scientific evidence that monthly menstruation is necessary for “cleansing the system,” or because it's a “natural” state.
Another possible benefit of monthly menstruation is that it serves as a sign that a woman is not pregnant, and menstruation is sometimes seen as a symbol of femininity, fertility, and youth.
Among other currently available medical options for reducing menstruation are injectable progestin-only contraceptives such as depot medroxyprogesterone acetate, a progestin-releasing intrauterine device (Mirena), oral progestins such as norethindrone acetate, danazol (a gonadotropin inhibitor with progestational and androgenic properties), gonadotropin-releasing hormone analogues such as leuprolide acetate, and extended regimens of the vaginal ring and the transdermal patch.
“All of the studies of extended cycling show more unscheduled bleeding and spotting in the beginning, and then it always gets a little better with time,” Dr. Westhoff said. “Very few women are amenorrheic at the beginning of continuous pill use.”
Although extended regimens of the vaginal ring and the transdermal patch seem to be safe and effective in clinical trials, Dr. Westhoff cautioned that uncertainties remain. For example, pharmacokinetic profiles suggest that steady-state ethinyl estradiol levels go a little higher each week than the week before. “We don't have data telling us what will happen with circulating levels if one would use the patch for 4, 6, 8, or 12 weeks,” she said.
Dr. Westhoff noted that her talk was prepared by an expert committee of the Association of Reproductive Health Professionals and was made possible by an unrestricted educational grant from Wyeth. Dr. Westhoff also disclosed receiving research support and serving as a consultant for Barr Pharmaceuticals and Organon.
Contemporary Forums and this news organization are wholly owned subsidiaries of Reed Elsevier.