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Extended-use contraception offers revolution in reproductive choices
Approval of dedicated product could eliminate barriers to acceptance
A young woman sits before you. She has an active lifestyle that requires her to travel a great deal. She is not interested in having children within the next year, and she is looking for convenient, effective contraception. What choices do you offer?
If any of the methods in your counseling strategy include extended use of hormonal contraception, then you join a growing number of clinicians who are responding to patients’ requests for birth control methods that reduce or eliminate the number of withdrawal bleeds.
To date, no oral contraceptive (OC) has been packaged for extended or continuous use. This may change this summer, though, if the Food and Drug Administration (FDA) approves Seasonale, the first extended regimen oral contraceptive. Under FDA review at press time, the proposed product, manufactured by Barr Laboratories of Pomona, NY, is designed with 84 continuous days of pills containing 150-mcg levonorgestrel and 30-mcg ethinyl estradiol, followed by seven placebo pills.
Researchers also are looking at extended use of the NuvaRing contraceptive vaginal ring (Organon, West Orange, NJ) and the Evra transdermal contraceptive (Ortho McNeil Pharmaceuticals, Raritan, NJ).
"Although women’s health clinicians have known for decades that the schedule used to prescribe OCs can be varied to reduce bleeding, the availability of dedicated extended OC packaging, and hopefully, educational programs to support this, will make choices regarding reduced bleeding much more available to women in the U.S.," says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. (Clinicians can learn more about extended contraception by attending one of the Washington, DC-based Association of Reproductive Health Professionals’ visiting faculty program sessions of "Choosing When to Menstruate." See the resource box at the end of this article for more information.)
Women want the choice
Recent surveys indicate that many women — regardless of age — would prefer to eliminate menses completely or reduce the frequency to less than once a month. The percentage of women desiring to stop having their periods increased with age, with more than half of menstruating women older than 45 preferring no periods at all.1
In 2002, ARHP commissioned a telephone survey to check women’s preferences on the frequency and characteristics of menstrual bleeding. The survey data showed that nearly two-thirds of women do not rely on their monthly periods to let them know if they are pregnant, able to have children, or are healthy.2 More than one in four women surveyed reported they have missed professional, social, athletic, or family-oriented events because of their period, menstrual cramps, or other menstrual effects.2
Using hormonal contraception for induced amenorrhea is not a new concept, points out John Guillebaud, MA, FRCSEd, FRCOG, MFFP, emeritus professor of family planning and reproductive health at University College in London. The concept has been around since at least the 1970s, with publication of research on reducing the frequency of menstruation with oral contraceptives, he notes.3
Further observations on the subject were spurred by the 1999 publication of the book Is Menstruation Obsolete?4 Co-author Sheldon Segal, PhD, distinguished scientist at the New York City-based Population Council, extends the argument in his new publication, Under the Banyan Tree: A Population Scientist’s Odyssey.5 Control of when or whether to menstruate is a new reproductive freedom that should be available to modern women, he says.
Clinicians are familiar with the long-term impact of the progestin-only contraceptive injection (depot medroxyprogesterone acetate or DMPA, marketed as Depo-Provera, Pharmacia Corp., Peapack, NJ) on bleeding profiles. During the first year of DMPA use, 30%-50% of women are amenorrheic, and by the fifth year, that number increases to 80%.6 The levonorgestrel intrauterine system (Mirena, Berlex Laboratories, Montville, NJ) also impacts the bleeding profile. In a long-term study, cessation of menstruation occurred in 47% of women.7
Providers also have become accustomed to manipulating the 21/7 packaging regimen of combined oral contraceptives to help bypass withdrawal bleeding for healthy women competing in athletic competitions or going on their honeymoons, as well as for women for whom bleeding poses a severe sanitary problem, such as for individuals with severe mental disabilities.8
In discussing extended contraception, it is important that clinicians and patients understand that a woman using OCs — or another combined hormone method — does not have an ovulatory cycle; it is stopped, and remains stopped, whether the hormones are taken on a 21-day schedule or for a longer regimen, observes Felicia Stewart, MD, adjunct professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco and co-director of the Center for Reproductive Health Research & Policy.
The only difference between the schedules is how often withdrawal bleeding occurs, explains Stewart. Bleeding in this situation occurs not because of a "cycle," but because the hormone level in the woman’s body (which comes from the OC) declines as soon as she stops taking the OC, and the decline causes whatever lining there is in the uterus to be shed, she states.
"The hormone dose in low-dose OCs, as well as patches or rings, is low enough that lining build-up is less than most women have with ovary hormone cycles, and as time goes on with extended use, the lining may become thin enough that the shedding’ is too little to see, [with] little or no visible blood," Stewart observes.
Clinicians may want to avoid the phrase "suppressed menses," because what is suppressed is ovulation, and that is true whether OCs are used in 21-day cycles or in longer cycles, Stewart suggests. She also believes that it may be misleading to talk about "regulating" a cycle. Using OCs or other combined hormonal methods actually eliminate the cyclic ovulatory changes, and "regulate" implies that "cycles" still are occurring, but just on a more predictable timetable, Stewart says.
Clinicians may be surprised at how meaningful involvement in decisions about pill-taking could affect a woman’s adherence to her chosen pill regimen, points out Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance in a 2000 review of the history of the Pill.9
"Can we imagine how well women would take their pills if they could use them to control when [and if] they menstruated?" wrote Nelson. "I think today would be a good day to find out."
The Washington, DC-based Association of Reproductive Health Professionals (ARHP) has scheduled several 2003 sessions of its visiting faculty program, "Choosing When to Menstruate." To check session dates, go to the ARHP web site, www.arhp.org. ARHP also has devoted an entire issue of its publication, Clinical Proceedings, to the subject. Review the issue here.
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. Association of Reproductive Health Professionals. Extended regimen oral contraceptives. Harris Poll. June 14-17, 2002.
3. Loudon, NB, Foxwell M, Potts DM, et al. Acceptability of an oral contraceptive that reduces the frequency of menstruation: The tri-cycle pill regimen. BMJ 1977; 2:487-490.
4. Coutinho EM, Segal SJ. Is Menstruation Obsolete? New York City: Oxford University Press; 1999.
5. Segal SJ. Under the Banyan Tree: A Population Scientist’s Odyssey. New York City: Oxford University Press; 2003.
6. Mishell DR, Kletzky OA, Brenner PF, et al. The effect of contraceptive steroids on hypothalamic-pituitary function. Am J Obstet Gynecol 1977; 128:60-74.
7. Baldaszti E, Wimmer-Puchinger B, Loschke K. Acceptability of the long-term contraceptive levonorgestrel-releasing intrauterine system (Mirena): A three-year follow-up study. Contraception 2003; 67:87-91.
8. Thomas SL, Ellertson C. Nuisance or natural and healthy: Should monthly menstruation be optional for women? Lancet 2000; 355:922-924.
9. Nelson AL. Whose pill is it, anyway? Fam Plann Perspect 2000; 32:89-90.