Contraception
Corner
Oral Contraceptives: Choose When—and
Whether—to Bleed
Anita L. Nelson, MD; Miriam Zieman, MD
When combined oral contraceptives (OCs) came to market in 1960, they
were developed to mimic women’s natural menstrual cycles. To
the creators of the "pill," this emulation had the advantage of increasing
acceptability of their novel contraceptive method. Their thinking
was that women could be reassured, on a monthly basis, that the pills
were working and they were not pregnant. In the past 43 years, we
have gained experience with other hormonal contraceptives that often
do not afford regular bleeding cycles: progestin-only injections,
implants, some pills, and others. These are effective and safe contraceptive
options acceptable to most women. It is logical then to ask whether
women would like the benefits of combined OCs, with the power to
choose if and when they have their withdrawal bleeds. The potential
advantages of extending the traditional 28-day cycle include fewer
bleeds and, therefore, fewer symptoms associated with menses or bleeding
(eg, dysmenorrhea, headaches, bloating, breast tenderness). And many
women would benefit from the added convenience of fewer periods.
Experience With Extended OC Regimens
Extending OC use for a medical indication such as endometriosis-related
pain therapy is well accepted. It is recommended to use pills continuously
for 6 to 12 months. Estrogen may be added if breakthrough bleeding
occurs.1
A study2 from 1977 investigated whether women would like a regimen
of taking active pills 84 days in a row, followed by 6 pill-free
days. The investigators found that 82% of 161 women welcomed the
reduction in the number of periods and associated symptoms. They
also found this regimen easier to follow.
A prospective study by Sulak et al3 followed 50 women with menstrual-related
symptoms. Each was given extended-use regimens that varied from 6
weeks to 12 weeks of active pills. Of the 50 women, 42% were using
pills for "medical" rather than contraceptive reasons (eg, they or
their partner were sterilized). The study found 74% of the patients
were stabilized on continuous OCs; most had shorter menses and fewer
symptoms during the pill-free interval, and 26% either discontinued
OCs or returned to the standard 3-week cycle of OC use. In another
study, Sulak et al4 examined the timing of hormone-related symptoms
in OC users, comparing active pill with hormone-free intervals. In
the study, 262 women provided daily records of hormone-related symptoms
(eg, pelvic pain, headaches, use of pain medication, bloating, and
breast tenderness). Almost all symptoms were significantly worse
during the 7-day hormone-free interval than during the 21 days of
hormone-containing pills. In another study of extended regimens,
Miller and Notter5 randomized 90 women to a traditional 28-day cycle
versus a 49-day cycle. They found that extension to a 49-day cycle
resulted in fewer bleeding days and no increase in mean spotting
days or bleeding episodes.
Who is an appropriate candidate for fewer
pill-free intervals?
- Women with symptoms related to hormone withdrawal. These include
premenstrual and menstrual symptoms (eg, bloating, mastodynia,
mood swings) as well as menstrual migraines or catamenial seizures.
Dysmenorrhea is commonly encountered and responds well to extended
OC use, as does endometriosis.
- Women with previous failures on cyclic OC use. Oral contraceptive
failures due to missed pills are more likely when pills are missed
just after the pill-free interval. This circumstance allows more
time for follicular development. There is less follicular development
when there is a shortened pill-free interval.
- Women for whom bleeding is problematic (eg, fibroids, adenomyosis,
bleeding disorders, menorrhagia).
- Women who want the convenience. This may be short term as is
traditionally done for honeymoons, or long term for those wishing
to reduce the number of menses experienced.
- Athletes and females in the military, especially when deployed.
- Active working women who cannot afford to miss work or school,
or who suffer performance impairment if they continue their daily
activities.
How to prescribe extended use or shortened
pill-free intervals
Most experts with familiarity prescribing these regimens recommend
using monophasic OCs to do this. This affords steady levels of hormones
as well as eliminating confusion as to which pill in the cycle a
woman is taking.
- Fixed patterns may be "bi-cycling" (taking two 21-day packs
continuously) followed by 3 to 7 days of a pill-free interval, "tri-cycling"(taking
three 21-day packs continuously), or any other chosen "cycle." The
key is not to allow, at any time, more than 7 days of a pill-free
interval; fewer days of placebo pills are preferred.
- Variable patterns allow a woman to use OCs continuously (for
at least 3 weeks) until she spontaneously bleeds or spots, then
to stop OCs and allow for a withdrawal bleed; this could be 2
to 7 days. The patient must understand that she should resume
taking pills even if she is still bleeding.
- Some experts recommend prescribing these patterns only after
an OC user has been on OCs for 3 traditional cycles, to allow
for the pills’ initial change on the uterine lining to
stabilize.
- A shortened pill-free interval can be achieved using desogestrel/
ethinyl estradiol and ethinyl estradiol tablets (Mircette), which
has 21 active combined pills followed by 2 days off, followed
by 5 days of ethinyl estradiol 10 mcg.
- A combined OC (Seasonale) recently has received approval by
the US Food and Drug Administration and is packaged as 84 active
pills (0.03 mg [30 mcg] ethinyl estradiol/0.15 mg levonorgestrel.)
followed by 7 days of placebo pills.
With the exception of this newly approved 84-day on/7-day off regimen,
extended regimens are "off-label" uses of regular combination OCs.
There is considerable published clinical experience with extended
and continuous OC use. Until studies reporting the safety and efficacy
of extended use are published, extended-use regimens will continue
to be "experimental" for other combined hormonal methods, such as
patches and rings. In October 2003, the Association of Reproductive
Health Professionals (ARHP) plans to release results from a study
on patient and provider perceptions about menstruation. In the meantime,
additional related research from ARHP's recent clinical proceedings
on extended regimen contraception may be accessed at www.arhp.org.
References
- Speroff L, Glass RH, Kase NG. Clinical Gynecologic Endocrinology
and Infertility. 6th ed. Baltimore, Md: Lippincott Williams & Wilkins;
1999: 1063-1064.
- Loudon NB, Foxwell M, Potts DM, Guild AL, Short RV. Acceptability
of an oral contraceptive that reduces the frequency of menstruation:
the tri-cycle pill regimen. Br Med J. 1977; 2(6085):487-490.
- Sulak PJ, Cressman BE, Waldrop E, Holleman S, Kuehl TJ. Extending
the duration of active oral contraceptive pills to manage hormone
withdrawal symptoms. Obstet Gynecol. 1997; 89(2):179-183.
- Sulak PJ, Scow RD, Preece C, Riggs MW, Kuehl TJ. Hormone withdrawal
symptoms in oral contraceptive users. Obstet Gynecol. 2000;95(2):261-266.
- Miller L, Notter KM. Menstrual reduction with extended use
of combined oral contraceptive pills: randomized controlled trial.
Obstet Gynecol. 2001;98(5 Pt 1):771-778.
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