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
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception · 2024 · vol. 30(1) , pp. 3–12 · doi:10.1080/13625187.2024.2398433 · PMID:39279689 · W4402555287
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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: Seven-hundred six and 288 participants received DNG/EE and DRSP/EE, respectively. Scheduled bleeding patterns per each 28-day cycle were similar in both groups. During Cycles 2-6, the proportion of participants with unscheduled bleeding/spotting was significantly lower in the DNG/EE group (50.5% [280/574] than in the DRSP/EE group (72.8% [171/235]]; treatment difference 22.3% [95% CI 15.9, 28.6%]; p < 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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MeSH descriptors

Androstenes Androstenes Androstenes Contraceptives, Oral, Combined Contraceptives, Oral, Combined Contraceptives, Oral, Combined Ethinyl Estradiol Ethinyl Estradiol Ethinyl Estradiol Nandrolone Nandrolone Nandrolone Nandrolone Adolescent Adult Delayed-Action Preparations Double-Blind Method Drug Combinations Female Humans

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