Combination oral contraceptive shows safety and efficacy

Key clinical point: An oral contraceptive combining 15 mg estetrol and 3 mg drospirinone prevented pregnancy and promoted predictable bleeding patterns in women aged 18 to 35 years compared with a placebo during a study period of up to 13 cycles.

Major finding:  The Pearl Index overall was 0.47 pregnancies per 100 women-years, and the method failure Pearl Index was 0.29 pregnancies per 100 women-years. Scheduled bleeding or spotting occurred in approximately 92% to 95% of the women during 12 cycles of contraceptive use.

Study details: The data come from an open-label, multicenter, phase 3 clinical trial including 69 sites in Europe and Russia. The study population included 1,553 women aged 18-30 years. The primary outcome measures were the Pearl Index measure of contraceptive effectiveness for women aged 18-35 years, bleeding patterns, and adverse events.

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Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Gemzell-Danielsson K et al. BJOG. 2021 Jul 10. doi: 10.1111/1471-0528.16840.