ISSUE 1420
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The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.1
CLINICAL STUDIES — In an unpublished open-label, single-arm study, 3565 women were treated with Quartette for up to 1 year (4 cycles). The pregnancy rate (Pearl Index) among women 18-35 years old, based on 70 on-treatment pregnancies, was 3.19 per 100 woman-years of use.2
An unpublished study, available only as an abstract, combined data from several clinical studies of extended-cycle combination oral contraceptives to compare the incidence of unscheduled
... more1. Choice of contraceptives. Treat Guidel Med Lett 2010; 8:89.
2. DJ Portman et al. Multicenter open-label study to evaluate efficacy and safety of an ascending-dose, extended-regimen ethinyl estradiol/levonorgestrel combination oral contraceptive for preventing pregnancy in women. Fertil Steril 2012; 98(3) Table 2. Some Vaginal Estrogen Products suppl:S196. Abstract P-285.
3. M Darwish et al. The PK/PD relationship of ethinyl estradiol and unscheduled bleeding or spotting for an ascending-dose, estrogen/progestin combination oral contraceptive (OC). Reprod Sci 2013; 20(3) suppl:193A. Abstract F-008.
5. CDC. US Medical eligibility criteria for contraceptive use, 2010. MMWR Recomm Rep 2010; 59(RR-4):1.
6. FDA. Quartette Summary Review. Available at http://www.accessdata.fda.gov. Accessed June 26, 2013.
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