Progestin-only pills: Where do they fit in?
Your next patient is a young mother who just gave birth to a healthy infant eight weeks ago. She is breast-feeding her baby and wants to use a safe method of contraception that will not affect her milk supply. What option will she choose?
If the selected method is the progestin-only pill (POP or mini-pill), your patient falls into a very small segment of contracepting women in the United States. According to the latest review of contraceptive trends, less than 1% of American women select the mini-pill for contraception.1
Use of mini-pills may be affected by their effectiveness; according to A Pocket Guide to Managing Contraception, about 5% of typical users will experience an accidental pregnancy in the first year, since some women do not take their pills correctly.2 However, if mini-pills are used consistently and correctly, just three out of 1,000 women will become pregnant.2
Prescribing practices for mini-pills call for women to take their pill within a three-hour window each day, which leaves little room for error. Now Cerazette, a new 75 mcg desogestrel mini-pill from Organon NV in Oss, the Netherlands, offers a wider missed window, which may lead to increased use of the progestin-only method.3
Unlike other POPs, which draw their effectiveness from thickening cervical mucus so that sperm cannot reach the egg, the desogestrel mini-pill works primarily by preventing ovulation.2 Based on Cerazette’s consistent inhibition of ovulation,4 European regulators in 2004 extended the drug’s missed pill window to 12 hours.3
While Cerazette is available in 53 countries, including the United Kingdom, Germany, France, Sweden, and several Latin American countries, it is not available in the United States, says Corina Ramers-Verhoeven, an Organon spokeswoman. Mini-pill options available in the United States include Ortho Micronor (0.35 mg norethindrone, Ortho-McNeil Pharmaceuticals, Raritan, NJ), Nor-QD (0.35 mg norethindrone, Watson Pharma, Corona, CA), Ovrette (0.075 mg norgestrel, Wyeth, Philadelphia), Camila (0.35 mg norethindrone, Barr Pharmaceuticals, Pomona, NY) and Errin (0.35 mg norethindrone, Barr Pharmaceuticals, Pomona, NY).
Since mini-pills do not contain estrogen, they represent a good contraceptive choice for breast-feeding women, as well as women with health conditions that preclude use of combined oral contraceptives. Candidates who may initiate POPs include:
- recently postpartum women;
- breast-feeding women;
- smokers older than age 35;
- women with multiple risk factors for arterial cardiovascular disease (such as older age, smoking, diabetes, and hypertension);
- women with an elevated blood pressure;
- women with past history of deep vein thrombosis or a pulmonary embolism;
- women with a known thrombogenic mutation;
- women with coronary artery disease or cerebrovascular disease;
- women with migraine headaches, with or without aura;
- women whose nausea, headaches, depression, or any other symptom has clearly become worse since starting on combined pills, the patch, or the ring;
- women who have or fear chloasma.2
Women who use progestin-only pills, including Cerazette, experience irregular bleeding, says John Guillebaud, MD, professor emeritus at University College London. The discontinuation rate for Cerazette is very similar to with old-type progestin-only pills, he observes.
Tell women that menstrual irregularity is the most common problem with mini-pills; while the amount of blood lost is less, bleeding may be at irregular intervals and there may be spotting between periods.2 However, with the absence of estrogen, women may not experience the nausea, headaches, and other symptoms associated with combined oral contraceptives.2 Mini-pill use may lead to decreased cramps and pain during periods; there also may be decreased pain at the time of ovulation in some women.2
For mini-pill users in the United States, clinicians should review what to do if a pill is taken three or more hours late. Counsel women to use a backup method of contraception, such as the condom, until 48 hours after pill-taking resumes.5
Take note if women report a history of gestational diabetes; mini-pills may not be the best choice for them. A study that focused on women with a history of gestational diabetes found that those who used progestin-only pills during breast-feeding were almost three times more likely to develop chronic noninsulin-dependent diabetes than women who used nonhormonal methods.6
References
- Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: 1982-2002. Advance Data from Vital and Health Statistics, No. 350. 2004.
- Hatcher RA, Zieman M, Cwiak C, et al. A Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2005.
- Organon NV. European regulators extend missed pill window for Cerazette — High contraceptive efficacy in a pill without estrogen. Press release. June 24, 2004. Accessed at: www.organon.com/news/2004_06_25_european_regulators_extend_missed_pill_window_for_cerazette.asp.
- Korver T, Klipping C, Heger-Mahn D, et al. Maintenance of ovulation inhibition with the 75-microg desogestrel-only contraceptive pill (Cerazette) after scheduled 12-h delays in tablet intake. Contraception 2005; 71:8-13.
- Family Health International. Using Progestin-only Pills Correctly. Fact sheet. Accessed at: www.FHI.org/en/RH/Pubs/factsheets/POcorrect.htm.
- Kjos SL, Peters RK, Xiang A, et al. Contraception and the risk of Type 2 diabetes mellitus in Latina women with prior gestational diabetes mellitus. JAMA 1998; 280:533-538.
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