Edelman Alison, Hemon Agnes, Creinin Mitchell, Borensztein Pascale, Scherrer Bruno, Glasier Anna
Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR, United States.
Laboratoire HRA Pharma, Chatillon, France.
JMIR Res Protoc. 2021 Jun 8;10(6):e29208. doi: 10.2196/29208.
Progestin-only contraceptive pills (POP) are commonly reserved for women with medical comorbidities but in actuality, POPs can be safely used by anyone wanting to prevent pregnancy. This wide safety profile makes them an ideal candidate for being available over the counter without a prescription, but adherence issues may be more common with over-the-counter use. We need a better understanding of the ability of POPs to prevent pregnancy when adherence issues occur in the form of a missed or delayed pill.
This study aims to determine cervical mucus characteristics following a 6-hour delayed pill intake or after one missed pill as compared to typical daily use of norgestrel 75 mcg.
This prospective, multicenter, randomized, crossover study assesses the effect of norgestrel 75 mcg (Opill) on cervical mucus and ovarian activity during reported compliant daily use, after a 6-hour delayed intake mid cycle, and after a mid-cycle missed pill. Subject participation will last approximately 4.5 months. We will recruit at 2 US sites: Oregon Health & Science University, Portland, Oregon and University of California Davis Health, Sacramento, California. Reproductive-aged subjects with regular menstrual cycles (21-35 days), BMI <32 kg/m2, and proven ovulation (screening luteal phase progesterone >3 ng/mL [>10 nmol/L]) are eligible to enroll. Participants cannot be at risk for pregnancy during the study period and not use other hormonal methods. Norgestrel 75 mcg will be taken at the same time daily except for one day in each of treatment periods 2 and 3, when the pill will be taken either 6 hours late (delayed pill) or omitted completely (missed pill). Every 3-4 days, we will monitor subjects for follicular activity with transvaginal ultrasound (TVUS) examination, cervical mucus, and blood sampling for ovarian hormones and gonadotropins. Subjects will undergo serial cervical mucus sampling on the days with missed and delayed pill intake at 8 hours after pill intake on the day before the delayed or missed pill, 3 hours following the scheduled time of pill intake if intake was delayed, 6 hours after the scheduled time if intake was omitted, and on the next day 30 minutes before the time of scheduled pill intake. The primary objective of the study is to determine the effect of a delayed or omitted pill intake on cervical mucus characteristics based on a modified Insler score compared to reported daily use.
Our protocol was successfully approved by a central institutional review board (Advarra, Columbia, MD), received ethical approval on March 23, 2018, and was registered with ClinicalTrials.gov (NCT03585712). As of January 2020, the study completed enrollment of 52 subjects. Analyses are pending.
Our protocol was approved by a central review board, and study procedures were successfully executed with completed proposed enrollment.
ClinicalTrials.gov NCT03585712; https://clinicaltrials.gov/ct2/show/NCT03585712.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29208.
仅含孕激素的避孕药（POP）通常留给有合并症的女性使用，但实际上，任何想要避孕的人都可以安全使用POP。这种广泛的安全性使其成为无需处方即可非处方购买的理想选择，但非处方使用时依从性问题可能更常见。我们需要更好地了解当以漏服或延迟服药的形式出现依从性问题时，POP预防妊娠的能力。
本研究旨在确定与每天服用75微克炔诺孕酮的常规用法相比，服药延迟6小时或漏服一剂后宫颈黏液的特征。
这项前瞻性、多中心、随机、交叉研究评估了75微克炔诺孕酮（奥皮乐）在报告的每日依从性使用期间、周期中期延迟服药6小时后以及周期中期漏服一剂后对宫颈黏液和卵巢活动的影响。受试者参与时间约为4.5个月。我们将在美国的2个地点招募受试者：俄勒冈州波特兰市的俄勒冈健康与科学大学和加利福尼亚州萨克拉门托市的加利福尼亚大学戴维斯分校健康中心。月经周期规律（21 - 35天）、体重指数<32 kg/m²且经证实有排卵（筛查黄体期孕酮>3 ng/mL[>10 nmol/L]）的育龄受试者有资格入选。研究期间，参与者不能有怀孕风险，且不能使用其他激素方法。除了在治疗期2和3的每一天，75微克炔诺孕酮将在每天同一时间服用，在这一天，药物将延迟6小时服用（延迟服药）或完全漏服（漏服）。每3 - 4天，我们将通过经阴道超声（TVUS）检查、宫颈黏液检查以及采集血样检测卵巢激素和促性腺激素来监测受试者的卵泡活动。在漏服和延迟服药的当天，受试者将在延迟或漏服前一天服药后8小时、如果服药延迟则在预定服药时间后3小时、如果漏服则在预定时间后6小时以及次日预定服药时间前30分钟进行连续宫颈黏液采样。本研究的主要目的是根据改良的因斯勒评分，确定与报告的每日使用情况相比，延迟或漏服药物对宫颈黏液特征的影响。
我们的方案已成功获得中央机构审查委员会（Advara，马里兰州哥伦比亚）的批准，于2018年3月23日获得伦理批准，并在ClinicalTrials.gov（NCT03585712）上注册。截至2020年1月，该研究已完成52名受试者的招募。分析工作正在进行中。
我们的方案已获得中央审查委员会的批准，研究程序已成功执行，且已完成预定的招募工作。
ClinicalTrials.gov NCT03585712；https://clinicaltrials.gov/ct2/show/NCT03585712。
国际注册报告识别码（IRRID）：DERR1-10.2196/29208。
