Hormonal contraceptives: The future has arrived

By Robert Hatcher, MD, MPH
Professor of Gynecology and Obstetrics
Emory University School of Medicine
Atlanta

When the first combined oral contraceptive entered the marketplace in 1960, women began taking hormonally active pills for 21 days, followed by seven days of placebo pills, or no pills at all. This 21/7 regimen resulted in regular withdrawal bleeding every month.

Such regular monthly cycles are a modern phenomenon. Women in hunter-gatherer societies had 50 periods in a lifetime. In colonial times, women had about 150 periods. Today, women have 450-500 periods, due in part to the 21/7 regimen of combined hormonal contraception. However, extremely large studies have demonstrated that only 10%-15% of all cycles are exactly 28 days. Pills taken 21/7 change this!

The now-familiar pattern of very regular monthly withdrawal bleeds is now being changed. The introduction of progestin-only contraceptives such as depot medroxyprogesterone acetate (DMPA or Depo-Provera, Pfizer, New York City), Norplant implants (Wyeth, Philadelphia; no longer manufactured), and the levonorgestrel intrauterine system have resulted in long-acting contraception with scanty or no bleeding.

Extended-regimen contraception

We now have a dedicated extended-regimen contraceptive, Seasonale (Barr Pharmaceuticals, Woodcliff Lake, NJ) which results in four scheduled withdrawal bleeds a year. Providers are reporting that women are using the transdermal patch and the vaginal ring in an extended or continuous form, both resulting in altered forms of bleeding.

Methods that Lead to Irregular Bleeding/Amenorrhea

  • Progestin-only pills
  • Norplant (no longer available)
  • Depot medroxyprogesterone acetate (DMPA)
  • Extended use of birth control pills
  • Extended use of the contraceptive patch
  • Extended use of the contraceptive vaginal ring
  • Levonorgestrel intrauterine system
  • Single-rod contraceptive implant (approvable status)

A recent survey indicates 77% of providers are prescribing extended contraception.1 I believe the future of hormonal contraception will be in the direction of the extended or continuous provision of hormones. This will result in patterns of bleeding that are completely different than the familiar regularity of scheduled withdrawal bleeds from pills taken 21/7. But the efficacy and safety of these new approaches will be comparable.

What is natural’?

Is it natural not to have periods? Providers often hear that question. Consider the history of prehistoric women, where "natural" meant pregnant, breast-feeding, and dead by age 50. Women prior to menarche and after menopause do not "store up" huge accumulations of endometrial tissue. Their endometrium (as is the case with women using pills continuously) is actually atrophic.

Women regularly experiencing inconvenience, messiness, blood loss, painful periods, cyclic migraines, and/or breast tenderness may be happier having periods less often or not at all.

Surveys tell us that many women, regardless of age, would prefer to eliminate menses completely or reduce their frequency to less than once a month.2 Given the opportunity to determine how frequently they would menstruate, 44% of all women surveyed said they would prefer never to menstruate, and this number increases to 59% for women ages 40-49.2

Answer the questions

The use of hormonal contraception in extended or continuous forms has raised several questions, such as:

  • Is it safe?

Evidence from the one-year trial of extended use of Seasonale and the six-month trial of continuous use of a 20-mg ethinyl estradiol/100-mg levonorgestrel pill indicate no untoward effects on the endometrium.3,4

  • Will it affect return to fertility?

Results from a German trial indicate a rapid return to fertility after discontinuation of an extended regimen.5 Women who switched from the extended regimen to the conventional regimen experienced a rapid reversal of amenorrhea, and those who desired pregnancy conceived soon after discontinuation.5

The good and the bad

The advantages of extended regimens of contraception include convenience, increased ovulation suppression, and minimized cyclic symptoms. Such advantages come with drawbacks, as women need to be counseled on the initial irregular bleeding and the eventual amenorrhea that accompany extended regimens.

When combined oral contraceptives were first introduced, the regularity of the monthly withdrawal bleeds initially was seen as an important factor in women accepting the method. With new dosing regimens emerging, we are seeing more irregular bleeding patterns. Extended contraception options offer women and their clinicians important new contraceptive options.

References

1. Association of Reproductive Health Professionals and National Association of Nurse Practitioners in Women’s Health. Annual meeting registrant survey. August-September 2002.

2. Association of Reproductive Health Professionals. Extended regimen oral contraceptives. Harris Poll. June 14-17, 2002.

3. Anderson FD, Hait H. Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception 2003; 68:89-96.

4. Kwiecien M, Edelman A, Nichols MD, et al. Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose oral contraceptive: A randomized trial. Contraception 2003; 67:9-13.

5. Wiegratz I, Hommel HH, Zimmermann T, et al. Attitude of German women and gynecologists towards long-cycle treatment with oral contraceptives. Contraception 2004; 69:37-42.