Beginning this month, women can obtain birth control pills that have been FDA-approved to serve a dual purpose: suppressing menstruation and preventing pregnancy.
But the arrival of Seasonale, an oral contraceptive that limits women’s periods to four times a year, has rekindled debate over whether or not it is natural or even healthy to menstruate.
For women who are considering oral contraceptives, or for the 16 million women who are taking birth control pills, the question of whether fewer periods is better is a complicated one.
Women take Seasonale pills 84 days in a row and have nine fewer periods each year. On regular cycle oral contraceptives, women take 21 pills in a row and have fewer instances of unscheduled bleeding.
Chemically, Seasonale isn’t any different than current contraceptives made of the synthetic hormones levonorgestrel and ethinyl estradiol. The price is also the same — about $1 a pill.
Barr Laboratories, the makers of Seasonale, have essentially repackaged a pre-existing oral contraceptive and enabled women to take hormones for nine extra weeks without having to buy an extra sets of pills. Barr Labs spokeswoman Carol Cox said the decision to limit periods to four times a year versus two times a year, for example, was based upon market research and suggestions from Eastern Virginia Medical School, the institution that helped Barr develop Seasonale.
Bruce Downey, Barr’s chief executive, said in a conference call that his company expects Seasonale to generate $15 to $40 million dollars in sales by June 30, 2004.
Sales may be adversely affected by the increase in breakthrough bleeding women experience while taking the extra hormones. Nearly 8 percent of the women involved in the Seasonale arm of the clinical trial discontinued taking the pill because of “unacceptable bleeding” compared to 2 percent of conventional regimen patients.
But according to Elizabeth Barlet, an obstetrician-gynecologist at University Hospital and Clinics, “with long-term use, breakthrough bleeding should decrease.”
Seasonale does offer advantages for women, however.
“It comes in handy when people have a prescription drug card,” said Lee Trammell, a doctor at the private health clinic Women’s Health Associates. “If someone takes cyclic birth-control pills, they may run out before the month ends. It’s a matter of convenience.”
Although Seasonale arrives in pharmacies this month, the Boone County Health Department probably won’t have the drug until sometime next year. The Missouri Family Health Council provides the health department with its drugs via Title X, a federal funding program established 30 years ago to provide family planning services. According to Sue Hilton, executive director of the Missouri Family Health Council, a public health price has not yet been established.
Research into the safety of extended use of oral contraception is limited.
Christine Hitchcock, a Canadian doctor at the Centre for Menstrual Cycle and Ovulation Research, presented a review of published data on extended use of oral contraceptives to the Society of Menstrual Research in June.
“There are a number of safety questions about extended cycle oral contraception for which there are no published data,” Hitchcock wrote in an e-mail. “At the moment, women are being told that Seasonale is safe, reversible, convenient and probably an improvement to their health. My reading of the literature suggests that data to support these claims is not yet available.”
Before the Seasonale clinical trial was published in the peer-reviewed journal Contraception, two other randomized controlled trials had been published comparing extended schedule oral contraceptives to the usual schedule.
These studies, published in 1993 and 2001 looked at shorter term menstrual suppression - 63 days and 42 days, respectively- and found that extended schedule oral contraceptives reduce the number of days of bleeding that occurs on pill-free days at the expense of irregular bleeding.
The long term effects of this practice have not been studied.
“We know very little about the menstrual cycle for all the drugs we give women,” said Susan Brown, a professor at the University of Hawaii in Hilo.
Brown said it is difficult to receive funding for women’s health research projects from the National Institutes of Health – so she funded her own study. Her results support the hypothesis that women have fewer health symptoms immediately after menstruation.
Brown said her study also indicates “increased immune activity directed to clearing the uterus and fallopian tubes of any possible pathogens introduced by sperm.”
Recently Brown submitted a grant to the NIH to investigate how health factors, such as immune system activity and energy levels, vary across the menstrual cycle.
“We hypothesize that some of these health indicators are affected by whether sperm are entering the females’ reproductive systems during intercourse and by whether females have modified their normal hormone profiles by taking oral contraceptives or by receiving Depo-Provera shots,” Brown wrote in an e-mail.
Depo-Provera injections contain progestin, a hormone that suppresses ovulation.
Brown’s research was inspired in part by Margie Profet, an advocate of menstruation and recipient of the MacArthur genius grant in 1993. Profet created a stir within the scientific community when she developed the theory that menstruation rids the body of pathogens brought into the body by sperm.
Although Profet has studied physics, she has no certified training in evolutionary biology. Her theory was dismissed by much of the scientific community. In a widely read scientific journal article, Beverly Strassmann of the University of Michigan, asserted that menstruation evolved because it is more efficient to menstruate than keep the uterus in a state of constant readiness.
Strassmann also suggests that menstrual suppression is the more natural state for women. Before birth control, women were pregnant more often and did not menstruate as often as women do today.
Yet, there have been no published studies that investigate the role of menstruation in removing pathogens from the body.
A Personal Choice
Regardless of the potential benefits of withdrawal bleeding, the medical community agrees that Seasonale has proved safe in the short term. When women are deciding between Seasonale and regular cycle contraception, most health care providers do not plan to counsel women any differently — they say it is a personal choice.
Barlet said that birth-control is a form of menstrual suppression with arbitrary time periods designated for bleeding. Because the withdrawal bleeding a woman experiences on the pill is in response to hormones in the pills it shouldn’t make a significant difference whether you bleed four times a year or 13.
Nurse Practitioner Kristin Metcalf-Wilson, a faculty member at the MU Sinclair School of Nursing, agrees.
“For years clinicians have been providing menstrual suppression through traditional methods of birth-control. It has its place in the market for those who suffer from different symptoms like migraine headaches and heavy bleeding and cramping,” Metcalf-Wilson said.
National Women’s Health Network Program and Policy Director Amy Allina said health care providers who tout the safety of menstrual suppression may be missing the point. “Some women are more comfortable with a monthly period,” she said, regardless of whether data shows it is safe.
Allina also wonders how teenagers may interpret a marketing campaign that advertises “just four periods a year.”
“We’ve been a little concerned about stigmatization of menstruation with young teens,” Allina said. For most women, she said, “there’s nothing unhealthy about getting a period every month.”