You can help women achieve success with extended regimen contraception

Counsel on early onset unscheduled spotting when beginning regimen

Since the extended regimen pill Seasonale (Barr Laboratories, Pomona, NY) hit pharmacy shelves in October 2003, it has become the fourth most-prescribed oral contraceptive in the United States.1 What do you need to know in counseling women about this new option?

The new pill regimen offers women the choice of highly effective contraception and menstrual regulation — a "win-win," says Linda Dominguez, RNC, NP, assistant medical director of the Albuquerque-based Planned Parenthood of New Mexico. The success of this choice can be ensured with thoughtful counseling regarding early unscheduled bleeding that should improve over time, she notes.

"If clinicians don’t pre-emptively give this important information, the woman may be discouraged or even frightened by the very thing she thought she was going to avoid — bleeding," says Dominguez.

As with starting any hormonal method (and often when switching methods), women experience unscheduled bleeding the first few months of use, says Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health. While Seasonale offers the benefit of withdrawal bleeding four times a year, regularity usually doesn’t happen right away.

"It is important to set expectations correctly so patients don’t become discouraged during those months when their body is adjusting to the hormones," she says.

Provide information

To help clinicians educate women on menstrual suppression, the Washington, DC-based Association of Reproductive Health Professionals (ARHP) has focused the latest issue of its Health & Sexuality quarterly publication on the subject. (See resource box below to get more information on accessing the publication on-line.) The issue provides information on the history of menstruation, women’s options for contraception and controlling menstruation, and tips for counseling women who use extended- or continuous-regimen contraception.

"In this issue of Health & Sexuality, we try to overcome the historical mindset that limiting or eliminating the menstrual cycle is unhealthy," reports Leslie Miller, MD, associate professor of obstetrics and gynecology at the University of Washington, Seattle, and special clinical advisor for the publication. "It is important that women and their health care provider understand the risks and benefits of menstrual suppression in the context of a women’s own body and needs so that she is well-informed when considering extended or continuous regimen contraception."

One common concern voiced by women is that the uterine lining will build up if a period does not occur every month. Explain to them that taking oral contraceptives (OC) keeps the normal uterine lining from breaking down and bleeding, and that the lining remains thin and does not need to be flushed out each month.2 Augment your counseling about menstruation with an Internet resource developed by Barr Laboratories, www.knowyourperiod.com, Dominguez suggests. (See the resource box below to obtain more information on Seasonale.)

Counsel women to expect early-onset, unscheduled spotting and bleeding when they begin using Seasonale or any other form of extended contraception, and use research to help assure them that these events will subside over time. In Seasonale’s clinical trial, the percentage of women who experienced breakthrough bleeding declined with each successive 91-day extended cycle, from a median of 12 days per cycle during the first cycle to a median of four days by the fourth cycle.3

Side effects with Seasonale are similar to those encountered on traditional OCs. In the clinical trial, which compared the drug to Nordette (King Pharmaceuticals, Bristol, TN), side effects included headache (20.6% for Seasonale vs 28.3% for Nordette), nausea (7.5% vs 8.9%), dysmenorrhea (5.7% vs 4.0%), and breast tenderness (3.5% vs 1.3%).3

While Seasonale offers the convenience of 91-day dosing, it is important to remind patients that the copay or cost of each prescription is based on a three-month supply. Patients should check with their individual health benefit plans to determine the reimbursement policy for this particular drug.

What’s your stance?

When it comes to menstrual suppression, do you see it as a safe practice? In a 2003 survey of female obstetricians/gynecologists conducted for the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG), physicians were nearly unanimous (99%) in the view that menstrual suppression is safe for their patients.4

Slightly more than half (53%) of the physicians said they had used menstrual suppression. Those younger than age 40 were more likely than those ages 40 and older to have tried such a regimen (59.2% vs. 42.5%).

While providers are knowledgeable about menstrual suppression and are comfortable with the practice, an October 2003 survey conducted for ARHP found women have differing viewpoints on the matter.5 Results of the survey, which queried women and providers, show that most women had never heard of using birth control pills to skip a period, despite the fact that most of the clinicians surveyed said they had prescribed contraception to suppress menstruation.5

Women and health care providers also disagree on the necessity of having a period every month, according to the survey results. While half of the women said they believed a menstrual period is necessary every month, just 7% of health care providers held a similar position. Both groups agreed that more education is needed on the topic.

More options to emerge?

Miller has worked with many women in continuous use of OCs, which requires one active pill every day without a pill-free or placebo week.

The goal of continuous regimen is amenorrhea or complete menstrual cycle suppression, but it is very common to have irregular bleeding in the first six months, she notes. She operates her own web site, www.noperiod.com, to provide information on the practice and has conducted research on extended and continuous regimens.6,7

"Typically, the bleeding is light and painless if low ethinyl estradiol dose OCs are used," Miller observes. "Because women will not have a week off every month, they do not need higher doses, and in fact, it is possible if higher doses of estrogen are used, it will cause more side effects and risk."

Continuous use is not yet approved by the Food and Drug Administration (FDA); however, research is under way to look at what formulation and dose works best for such use, she reports. If research can show the practice is safe and effective, look for the introduction of a continuous pill, Miller predicts. (Editor’s note: CTU will keep you updated in future issues on research regarding continuous use.)

References

1. Hardy K. Use of EVMS contraceptive soars. The Virginian-Pilot. May 15, 2004; accessed at home.hamptonroads.com/stories/story.cfm?story=70353&ran=51850.

2. Association of Reproductive Health Professionals. Choosing when to menstruate: the role of extended contraception. Clinical Proceedings 2003; accessed at: www.arhp.org/healthcareproviders/onlinepublications/healthandsexuality/extendedregimen/faqs.cfm.

3. Anderson FD, Hait H. A multicenter randomized study of an extended cycle oral contraceptive. Contraception 2003; 68:89-96.

4. American College of Obstetricians and Gynecologists. Gallup Survey Reveals Women OB-GYNs Benefit from "Insider Knowledge." Washington, DC. Dec. 9, 2003. Accessed at: www.acog.org/from_home/publications/press_releases/nr12-09-03-2.cfm.

5. Association of Reproductive Health Professionals. Latest issue of Health & Sexuality magazine explores women’s options for controlling their periods. Washington, DC; May 3, 2004.

6. 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.

7. Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: A randomized trial. Obstet Gynecol 2003; 101:653-661.

Resources

  • To read the Association of Reproductive Health Professionals’ free issue of Health & Sexuality about menstrual suppression, go to the organization’s web site, www.arhp.org. Click on "Healthcare Providers;" "Online Publications;" "Health & Sexuality Magazine;" and "Taking Charge of Menstruation."
  • For more information on Seasonale, call (800) 719-FOUR (3687), a toll-free number operated by Barr Laboratories for health care professionals and women, or visit the product web site, www.seasonale.com. The site contains prescribing information as well as information on clinical studies.