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Help educate for success with extended pill use
For patients who are considering extended or continuous use of combined oral contraceptives (OCs), thorough counseling is an important aspect of ensuring success with the method.
Irregular bleeding during the first months of use is to be expected, so counsel women on this fact, advises 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. She operates her own web site, www.noperiod.com, which provides information for female patients and providers on how to use continuous OC regimens.
Miller, who has worked with both types of regimens,1,2 says she tells women to expect some bleeding up into six months of use.
"There is a light at the end of the tunnel," she notes. "By six months, 70% don’t have bleeding; by one year, 90%."
In her practice, Miller says she may switch a patient with persistent bleeding who is on continuous use of pills from Alesse (Wyeth-Ayerst Laboratories, Philadelphia) to Loestrin 1/20 (Galen Holdings, Rockaway, NJ), believing that the difference in progestins may lessen the symptom. She holds to using no higher than 20-mcg ethinyl estradiol pills for continuous regimens.
"I find it works better, with less bleeding," Miller comments. "Since one is taking it every day, it is more than an cyclic 20 mcg dose, so theoretically a 30 mcg ethinyl estradiol pill taken every day could expose the woman to the equivalent of a higher estrogen dose, which could mean more risk of thrombosis."
Women need a basic explanation of physiology to understand the absence of withdrawal bleeds, which occur during traditional regimen use, says Larry Seidman, DO, MBA, of Philadelphia Women’s Research. He is an investigator in the extended regimen trial of the contraceptive vaginal ring NuvaRing (Organon, West Orange, NJ).
Counsel that the bleeding that oral contraceptive users experience each month bears little biological resemblance to a menstrual period; indeed, there is little built-up uterine lining to be shed for these women.3 The bleeding women experience during the pill-free interval results from a drop in the hormone levels after the 21st day when active tablets have been completed and placebo pills are used.3
How to get pills?
How do you prescribe pills past the 21/7 regimen? Miller says she writes the prescription a certain way, first specifying the brand, then indicating "one birth control pill every day, active drug only, no spacer pills," and giving a medical reason for menstrual suppression, such as endometriosis, dysmenorrhea, or premenstrual syndrome (PMS). She then specifies 84 pills with four refills.
"One concern women have is getting enough pills to do it," says Miller. "Going to the pharmacy every 21 days is a barrier."
Until there is a dedicated OC product with an approved regimen outside the traditional 21/7 framework, women may have concerns about the safety and efficacy of such drug use. The Washington, DC-based Association of Reproductive Health Professionals (ARHP) has developed a free patient handout, "Frequently Asked Questions on Extended Contraception," to answer frequently asked questions on the method. (The handout is included in the April 2003 issue of the ARHP publication Clinical Proceedings. See the resource box at the end of this article to obtain the issue.)
Women are exposed to more hormones with an extended or continuous regimen; the annual consumption in milligrams of estrogen and progestin is 23% greater in women using a trimonthly OC regimen (84 days of hormones followed by seven placebo days) vs. the standard 21/7 regimen.4 However, this increased level of exposure is still below that of women using 50 mcg ethinyl estradiol pills.4
No study has examined the long-term safety of an extended OC regimen.4 According to published reports, about 350 women from the Phase III trial of Seasonale, the extended-regimen pill under review by the Food and Drug Administration at press time, will be followed for another two years to assess side effects and continuation rates.
"A woman who would choose to use the new product, Seasonale, would be exposed to, over the course of several months without a break, far less steroid medication than her mother did on a three-week-on, one-week-off regimen," says Sheldon Segal, PhD, distinguished scientist at the New York City-based Population Council and co-author of the book Is Menstruation Obsolete?5 "As for the risk on ovulation and menstruation suppression without interruption, we know from the large experience with Depo-Provera and Norplant, for example, that this is not a health risk."
Women do need to realize that because they will be eliminating the pill-free intervals, they will be using more packs of pills, says John Guillebaud, MA, FRCSEd, FRCOG, MFFP, emeritus professor of family planning and reproductive health at University College in London.
"If I were marketing a [pill] like this, I would want to say to the woman up front, You will be taking more hormones per year,’" he says. "But if you feel the advantages of not bleeding, not having to use tampons, are enough to compensate for that question mark, that small question mark, go for it."
"Choosing When to Menstruate" is the focus of the April 2003 issue of the Washington, DC-based Association of Reproductive Health Professionals’ (ARHP) publication Clinical Proceedings. Review the issue on-line at the ARHP web site, www.arhp.org.
1. Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: Randomized controlled trial. Obstet Gynecol 2001; 98(5 Pt 1):771-778.
2. Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: A randomized trial. Obstet Gynecol 2003; 101:653-661.
3. Thomas SL, Ellertson C. Nuisance or natural and healthy: Should monthly menstruation be optional for women? Lancet 2000; 355:922-924.
4. Suppression of menstruation with extended OC regimens. Contraception Report 2002; accessed at: www.contraceptiononline.org/contrareport/article01.cfm?art=223.
5. Coutinho EM, Segal SJ. Is Menstruation Obsolete? New York City: Oxford University Press; 1999.