Research eyes extending the menstrual cycle
Would women miss having monthly menstruation if given the choice? In Europe and Australia, many women already manipulate their oral contraceptive (OC) pill packs to reduce monthly periods,1 and U.S. providers routinely prescribe extended OC use for problems such as menstrual migraines. To date, however, there are no products approved or packaged for extended OC use in the United States.
"Menstruation can be optional, and certainly will be in the coming years with the large number of approaches to menstruation suppression that will be available to women," says Sheldon Segal, PhD, distinguished scientist at the Population Council and an adjunct professor of clinical pharmacology at Cornell Medical School, both based in New York City. Segal is co-author of Is Menstruation Obsolete? a book that examines the advantages of menstrual suppression.2
U.S. women and their clinicians are increasingly recognizing advantages associated with experiencing less frequent uterine bleeding, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. For some women, dysmenorrhea, menorrhagia, or other specific health issues motivate the desire for fewer menstrual periods, while other women may prefer fewer or no menses simply to avoid the inconvenience and/or unpleasantness of monthly bleeding episodes, he observes.
Newly published information offers more information about the safety of extended use of active OC tablets. In the research, investigators found that by extending the use of active pills, women had a 49-day menstrual cycle instead of the usual 28-day cycle, resulting in fewer bleeding days and no increase in breakthrough bleeding days.3 Women on the 49-day cycle reported fewer symptoms such as headaches and spent about half as much on menstrual products than those on the 28-day cycle.
Drug companies are eyeing the development of an extended-cycle OC. Barr Laboratories of Pomona, NY, is seeking Food and Drug Administration (FDA) approval for its four-periods-per-year pill, Seasonale, which uses a patented 84-day dosing regimen. If the drug is approved, it may be available in 2003, according to company sources. (See the May 1999 CTU article, "4-periods-a-year pill eyed for use in U.S.," for more information on Seasonale. Past CTU articles are available on the web site: www.contraceptiveupdate.com.)
The just-published OC research involved the use of Lo/Ovral-28, a 30 mcg ethinyl estradiol/0.3 mg norgestrel pill. Its manufacturer, Wyeth-Ayerst Laboratories of Philadelphia, declined to state if it is considering FDA approval for an extended-cycle pill.
Pursuit of a dedicated product is high on the list for Leslie Miller, MD, assistant professor of obstetrics and gynecology at the University of Washington and family planning medical director at Public Health — Seattle and King County, both in Seattle. Miller served as co-author for the study and has launched an informational web site on menstrual suppression, www.noperiod.com.
"Overall, my hope is that someday there will be an FDA-approved, labeled, low-dose OC pill packaged in a large volume, and just as with [hormone replacement therapy], women will come to realize taking a week off the pill only induces bleeding, cyclic symptoms, irregular bleeding, and pill failure," states Miller.
Review the history
Historically, women without access to contraception could have as few as 50 menstrual cycles in a lifetime, due to multiple pregnancies and a shorter life span than that of women today. In contrast, the modern woman can have up to 450 cycles.3
The current OC regimen of 21 active pills and seven placebo pills was designed to mimic the normal menstrual cycle, even though it is unnecessary for contraceptive efficacy.4 Pill users experience a withdrawal bleed for one week out of each 28 days, when the hormonal pills are not taken.
The pill-free interval brings its own set of symptoms. A study designed to measure the timing, frequency, and severity of hormone-related symptoms in OC users compared symptoms in active-pill and hormone-free intervals.5 Almost all symptoms were significantly worse during the seven-day hormone-free interval than during the 21 days of hormone-containing pills.
Segal sees the main advantage of menstrual suppression in its positive effect on a variety of health issues. Evidence shows a strong correlation between the number of menstrual cycles and the risk of ovarian, endometrial, and breast cancer; the lower the number of cycles, the lower the risk, or greater the protective effect, says Segal. In the case of ovarian cancer, the risk is reduced by 40% in OC users in comparison to nonusers6, Segal observes. In addition, menstruation-related problems, such as premenstrual syndrome, dysmenorrhea, and menorrhagia, are relieved through menstrual suppression.
"However, the most important benefit for women around the world is [the reduction of] anemia," says Segal. "A very large percentage of women in developing countries are anemic to begin with, so losing another 60-70 cc of blood a month is just irreplaceable iron loss."
Further research is needed on the proper pill formulation for suppression, since not all pills are suited for the task, says Miller.
"Phasic preparations, with weekly dosing amount variation, would destabilize the endometrium, and it is possible the extra week of estrogen could produce a higher estrogen effect if higher than 20 mcg ethinyl estradiol doses are used," she notes.
While the Pill is one of the most studied drugs in terms of safety and efficacy, the body of research is focused on the 21/7 regimen, Segal observes. He supports further research on the effects of menstrual suppression with current OC formulations.
"There should be some additional attention as to what are the health effects or possible side effects of continuous administration," states Segal. "I think we have some presumptive evidence, but we need some empirical evidence."
References
1. Den Tonkelaar I, Oddens BJ. Preferred frequency and characteristics of menstrual bleeding in relation to reproductive status, oral contraceptive use, and hormone replacement therapy use. Contraception 1999; 59:357-362.
2. Coutinho EM, Segal SJ. Is Menstruation Obsolete? New York: Oxford University Press; 1999. Updated and translated from an earlier work in Portuguese by EM Coutinho titled Menstruacão, a Sangria Inutil. Sao Paolo: Editora Gente; 1996.
3. Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: Randomized controlled trial. Obstet Gynecol 2001; 98:771-778.
4. Thomas SL, Ellertson C. Nuisance or natural and healthy: Should monthly menstruation be optional for women? Lancet 2000; 355:922-924.
5. Sulak PJ, Scow RD, Preece C, et al. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol 2000; 95:261-266.
6. Speroff L, Darney PD. A Clinical Guide for Contraception. Baltimore: Williams & Wilkins; 1992.
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