Generating evidence to improve same-day etonogestrel implant insertion for emergency contraception

生成证据以改善紧急避孕的当天依托孕烯埋植剂植入

• 批准号: 10561005
• 负责人: Lori Marie Gawron
• 金额: $ 61.07万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10561005
• 关键词: Address; Age; Body mass index; Categories; Client; Clinic; Clinical; Clinical Data; Clinical Research; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Counseling; Data; Eligibility Determination; Enrollment; Equity; Etonogestrel; Expert Opinion; Family Planning; Fertility; Frequencies; Goals; Guidelines; Hour; Human; Implant; Implantation procedure; Individual; Infrastructure; Intrauterine Devices; Levonorgestrel; Life; Menstruation; Methods; Monitor; Oral; Ovulation; Participant; Persons; Pharmacy facility; Placebo Control; Placebos; Plan B; Planned Parenthood Federation of America; Postcoital Contraception; Pregnancy; Pregnancy Tests; Progesterone; Progestins; Provider; Publications; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Risk; Role; Sales; Self Determination; Serum; Sexual Health; Site; Synthetic Progestogens; Time; Unsafe Sex; Urine; Utah; Woman; Work; avoid pregnancy; clinical practice; comparative efficacy; contraceptive efficacy; contraceptive practice; cost; emergency contraception; evidence base; experience; follow-up; high body mass index; improved; interest; placebo group; point of care; preference; prevent; primary outcome; prospective; randomized placebo controlled trial; reproductive; subcutaneous; trial comparing

PROJECT SUMMARY/ ABSTRACT Oral emergency contraception (EC), is commonly used after recent unprotected intercourse to avoid undesired pregnancy, but does not provide ongoing contraception. Rigorous data allow for use of intrauterine devices (IUDs) as both EC and ongoing contraception, but EC efficacy data on use of the etonogestrel (ENG) implant, is lacking. The CDC Selected Practice Recommendations for Contraceptive Use support initiation of the ENG implant if oral levonorgestrel (LNG) is given concomitantly for EC. This recommendation lacks supporting evidence and serves as a barrier to method initiation, as oral LNG is not typically available in clinics when clients desire an implant. Additionally, oral LNG efficacy decreases in higher body mass index (BMI) users and the role of BMI on efficacy with co-administered oral LNG and the ENG implant is unknown. As the ENG implant is also a synthetic progestogen with a rapid rise and consistent systemic levels, it could plausibly serve as stand-alone EC or increase the efficacy of oral LNG with co-administration. Moreover, the EC mechanism of action, which is related to ovulatory suppression with oral EC, may differ if the implant is initiated with or without oral LNG, impacting efficacy in mid cycle users. This study addresses the following research gaps around use of the ENG implant for EC that serve as barriers to provider comfort with these options: efficacy with and without oral LNG, efficacy differences by BMI, and ovulation frequency with and without oral LNG. We propose a randomized, placebo-controlled, non-inferiority study to determine if the ENG implant alone is no worse than the ENG implant + oral LNG for EC, using a 3.5% non-inferiority margin. We will include clients who present to Planned Parenthood Association of Utah clinics with report of unprotected intercourse within 72 hours who desire EC. Eligible EC clients interested in an implant with a negative pregnancy test will be allocated 1:1 to a study group: (1) ENG implant + oral LNG or (2) ENG implant + placebo. Our experienced research staff will follow up with participants for 4-week efficacy data as primary outcome. Our aims include: (1) To compare the efficacy of the ENG Implant + oral LNG to the ENG Implant + placebo for EC in 790 participants assessed by pregnancy status four weeks after implant placement, (2) To compare pregnancy risk by BMI category (we anticipate half of the 790 participants will have a BMI ≥25) between and within the ENG Implant + oral LNG and the ENG Implant + placebo groups, and (3) To evaluate ovulation frequency within 5 days of insertion of ENG Implant + oral LNG or ENG implant + placebo in 202 participants who are mid cycle (day 7-14 post menses) at time of enrollment assessed by serum progesterone levels and urine fertility monitor results. Our short-term goal is to expand evidence on the efficacy of implant initiation with or without oral LNG to meet the needs of EC clients. Our long-term goals are to develop evidence-based clinical guidelines to inform global contraceptive practices, allow for equity in LARC counseling at the time of EC, and support reproductive autonomy for people to achieve to their life goals.

项目总结/摘要 口服紧急避孕药（EC）通常在最近的无保护性交后使用，以避免不必要的 怀孕，但不提供持续避孕。严格的数据允许使用宫内避孕器 （宫内节育器）作为EC和持续避孕，但使用依托孕烯（ENG）植入剂的EC疗效数据， 缺乏。疾病控制和预防中心关于避孕药具使用的选择性实践建议支持启动ENG 如果同时口服左炔诺孕酮（LNG）治疗EC，则植入。这项建议缺乏支持 证据并成为方法启动的障碍，因为当诊所通常不提供口服液化天然气时， 客户希望植入。此外，口服LNG的功效在较高的体重指数（BMI）使用者中降低， BMI对口服LNG和ENG植入物联合给药的疗效的作用尚不清楚。作为ENG 植入物也是一种合成孕激素，具有快速上升和一致的全身水平，它可以合理地服务于 作为独立EC或增加口服LNG与联合给药的功效。此外，欧盟委员会的机制， 与口服EC的排卵抑制相关的作用可能不同， 没有口服LNG，影响中周期使用者的功效。本研究解决了以下研究空白 围绕使用ENG植入物治疗EC，这些选项阻碍了提供者的舒适度：疗效 有和没有口服液化天然气，疗效差异的BMI，排卵频率有和没有口服液化天然气。 我们建议进行一项随机、安慰剂对照、非劣效性研究，以确定单独使用ENG植入物是否 对于EC，使用3.5%的非劣效性界值，比ENG植入+口服LNG更差。我们将包括客户 向犹他州诊所计划生育协会报告72年内无保护性交的人 想看EC的人对妊娠试验阴性的植入物感兴趣的合格EC客户将 按1：1分配至研究组：（1）ENG植入物+口服LNG或（2）ENG植入物+安慰剂。我们经验丰富 研究人员将随访参与者4周的疗效数据作为主要结局。我们的目标包括： (1)在790例患者中比较ENG植入物+口服LNG与ENG植入物+安慰剂治疗EC的疗效 种植体植入4周后通过妊娠状态评估参与者，（2）比较妊娠风险 根据BMI类别（我们预计790名参与者中有一半的BMI ≥25）， 植入+口服LNG和ENG植入+安慰剂组，以及（3）在5分钟内评估排卵频率 在202例周期中期受试者中插入ENG植入物+口服LNG或ENG植入物+安慰剂的天数 (day 7-14月经后），通过血清孕酮水平和尿生育监测器评估 结果我们的短期目标是扩大证据的有效性种植开始或不口服液化天然气 以满足客户的需求。我们的长期目标是制定循证临床指南， 告知全球避孕做法，允许在EC时LARC咨询的公平性，并支持 生育自主权是人们实现其人生目标的基础。