Estetrol-Drospirenone Combination Oral Contraceptive
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Estetrol (E4) and drospirenone (DRSP) is an effective oral contraceptive with a predictable bleeding pattern, finds a study by Contraception.

The study aimed to assess the efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15mg and drospirenone (DRSP) 3mg.

Women aged 16-50 years with a BMI ?35 kg/m2 enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was scheduled at Cycles 2, 4, 7, and 10 and within 3 weeks of completing cycle 13. Participants used daily diaries to record pill use and vaginal bleeding.

They evaluated efficacy outcomes in women 16-35 years and bleeding patterns and safety in all participants. They assessed overall and method-failure pregnancy rates using the Pearl Index (PI) and life-table analysis. Scheduled bleeding included spotting or bleeding starting during the 4-day placebo period or the first 3 days of the next cycle. We enrolled 1,864 women of whom 1,674 were 16-35 years.

--Women 16-35 years had a PI of 2.65, method-failure PI of 1.43, and a 13-cycle life-table pregnancy rate of 2.1%.

--Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle; median duration was 4.5 days.

--Unscheduled bleeding decreased from 30.3% in Cycle 1 to 21.3-22.1% during Cycles 2-4 and remained stable thereafter.

--The most frequently reported AEs were headache, and metrorrhagia.

--One-hundred thirty-two women discontinued the study early for an AE, most commonly for metrorrhagia and menorrhagia. No thromboembolic events occurred.

In particular, E4/DRSP is an effective oral contraceptive with a predictable bleeding pattern for most women and low AE rates.

Source: https://doi.org/10.1016/j.contraception.2021.05.002
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