A randomised double-blind trial to determine the bleeding profile of the prolonged-release contraceptive dienogest 2 mg/ethinylestradiol 0.02 mg versus an immediate-release formulation of drospirenone 3 mg/ethinylestradiol 0.02 mg

Kristina Biskupska-Bodova, Joanna Sójka-Kupny, Tamás Nyirády, Anne E. Burke, Alicyoy Angulo, Pedro‐Antonio Regidor
In: The European Journal of Contraception & Reproductive Health Care · 2024 · vol. 30(1) , pp. 3–12 · doi:10.1080/13625187.2024.2398433 · PMID:39279689 · W4402555287
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This trial found that prolonged-release dienogest 2 mg/ethinylestradiol 0.02 mg significantly reduced unscheduled bleeding and spotting compared to immediate-release drospirenone 3 mg/ethinylestradiol 0.02 mg.

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Abstract

BACKGROUND: Dienogest (DNG) 2 mg/ethinylestradiol (EE) 0.02 mg is the first low-dose combined oral contraceptive (COC) with a prolonged-release formulation that allows stable plasma concentrations and has high contraceptive efficacy (Pearl index: 0.2). The aim of this trial was to determine the bleeding profile of this contraceptive compared to an immediate release formulation. METHODS: This prospective double-blind randomised controlled trial evaluated the bleeding patterns of DNG 2 mg/EE 0.02 mg compared with immediate-release drospirenone (DRSP) 3 mg/EE 0.02 mg in a 24/4-day regimen over nine cycles (randomisation ratio, 5:2). Participants recorded scheduled and unscheduled bleeding/spotting data using an electronic diary. A non-inferiority analysis for the proportion of participants with unscheduled bleeding/spotting was prespecified for Cycles 2-6. Safety, including adverse events, were monitored throughout the trial. RESULTS: < 0.0001). A low proportion of participants discontinued the trial due to bleeding disorders (1.7% and 0.7%, respectively). The safety profiles were similar for both treatments. CONCLUSIONS: The prolonged-release DNG 2 mg/EE 0.02 mg offers a significant decrease in unscheduled bleeding/spotting compared with an immediate-release COC, DRSP/EE, combined with high contraceptive efficacy and a very low adverse event profile.

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