Summary

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• Nextstellis (drospirenone and estetrol) is indicated for use by females of reproductive potential to prevent pregnancy.
• This summary is based on the review of four randomized controlled trial(s). ^[1-4]
• Pearl Index (PI) for women aged 18-35 years was 0.47 pregnancies per 100 woman-years (95% CI 0.15-1.11). Method-failure PI was 0.29 pregnancies per 100 woman-years (95% CI 0.06-0.83). Scheduled bleeding/spotting occurred in 91.9-94.4% of women across 12 cycles with a median duration of 4-5 days per cycle; unscheduled bleeding decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onward.
• Pooled Pearl Index (PI) was 1.52 pregnancies per 100 participant-years (95% CI 1.04-2.16), with a 13-cycle life-table pregnancy rate of 1.28% (95% CI 0.83-1.73%). PI was higher in younger participants (16-25 years: PI 1.61, 95% CI 0.94-2.57) compared to those aged 26-35 years (PI 1.43, 95% CI 0.78-2.40), and higher BMI was associated with increased PI (BMI ≥30 kg/m²: PI 2.27, 95% CI 0.83-4.94).
• Pearl Index (PI) for women aged 16-35 years was 2.65 pregnancies per 100 woman-years (95% CI 1.73-3.88), with a method-failure PI of 1.43 (95% CI 0.7-2.39) and a 13-cycle life-table pregnancy rate of 2.1%. Scheduled bleeding occurred in 82.9%-87.0% of women per cycle with a median duration of 4.5 days; unscheduled bleeding decreased from 30.3% in Cycle 1 to 15.5%-19.2% after Cycle 4.
• Common AEs included headache (7.7%), metrorrhagia (5.5%), vaginal hemorrhage (4.8%), and acne (4.2%). One treatment-related serious AE was lower extremity venous thromboembolism. Treatment-related AE discontinuation rate was 9.1%.
• Common treatment-related AEs were bleeding complaints (9.5%), breast pain/tenderness (4.0%), acne (3.3%), and mood disturbance (3.2%). Serious AEs included one venous thromboembolism, one worsening of depression, and one ectopic pregnancy. Discontinuation due to treatment-related AEs was 8.0%. No clinically relevant changes in weight, blood pressure, heart rate, or laboratory parameters.
• Common AEs were headache (5.0%) and metrorrhagia (4.6%). No thromboembolic events were reported. AE-related discontinuation was 7.1%, most commonly due to metrorrhagia (0.9%) and menorrhagia (0.8%).
• There is no population type or subgroup information available in the reviewed studies.