Biskupska-Bodova Kristina, Sójka-Kupny Joanna, Nyirády Tamás, Burke Anne E, Angulo Alicyoy, Regidor Pedro Antonio
Aetas, Private Gynecology Practice, Turcianske Teplice, Slovakia.
Department of Gynecology and Obstetrics, University Hospital, Martin, Slovakia.
Eur J Contracept Reprod Health Care. 2025 Feb;30(1):3-12. doi: 10.1080/13625187.2024.2398433. Epub 2024 Sep 16.
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.
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.
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%]; < 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.
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.
地诺孕素（DNG）2毫克/炔雌醇（EE）0.02毫克是首个具有延长释放制剂的低剂量复方口服避孕药（COC），其能使血浆浓度稳定且具有高避孕效果（ Pearl指数：0.2）。本试验的目的是确定与速释制剂相比，这种避孕药的出血情况。
这项前瞻性双盲随机对照试验评估了在24/4天方案下，九个周期内，2毫克DNG/0.02毫克EE与3毫克炔诺酮（DRSP）/0.02毫克EE速释制剂相比的出血模式（随机化比例为5:2）。参与者使用电子日记记录计划内和计划外的出血/点滴出血数据。预先设定了第2至6周期计划外出血/点滴出血参与者比例的非劣效性分析。在整个试验过程中监测安全性，包括不良事件。
分别有706名和288名参与者接受了DNG/EE和DRSP/EE治疗。两组中每个28天周期的计划内出血模式相似。在第2至6周期，DNG/EE组计划外出血/点滴出血的参与者比例（50.5%[280/574]）显著低于DRSP/EE组（72.8%[171/235]）；治疗差异为22.3%[95%CI 15.9, 28.6%]；P<0.0001）。因出血障碍而停止试验的参与者比例较低（分别为1.7%和0.7%）。两种治疗的安全性概况相似。
与速释COC（DRSP/EE）相比，延长释放的2毫克DNG/0.02毫克EE能显著减少计划外出血/点滴出血，同时具有高避孕效果和极低的不良事件发生率。
