Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1-2]
• The Pearl Index (PI) for women aged 16 to 35 using E4/DRSP was 2.65 (95% CI (Confidence interval) 1.73-3.88), with a method-failure PI of 1.43 (95% CI 0.7-2.39). The 13-cycle life-table pregnancy rate was 2.1%, indicating acceptable contraceptive efficacy within this age group.
• Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle, with a median bleeding duration of 4.5 days. Unscheduled bleeding decreased from 30.3% in Cycle 1 to 15.5%-19.2% after Cycle 4, showing improved cycle control over time.
• The effectiveness and safety data, including a lack of thromboembolic events, were consistent with other available oral contraceptives, specifically assessed in women aged 16 to 35 years, with no significant differences reported among other population subgroups.
• The most frequently reported adverse events for E4/DRSP were headache (5.0%) and metrorrhagia (4.6%), with 7.1% of participants discontinuing the study early due to an adverse event, primarily metrorrhagia (0.9%) and menorrhagia (0.8%). Importantly, no thromboembolic events were reported.
• The safety profile of E4/DRSP was comparable to other oral contraceptives, but further large phase 4 studies are needed to assess whether this combination may have a lower thrombosis risk relative to other options.