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.

项目摘要/摘要 口服紧急避孕（EC），通常是在最近未受保护的性交后通常使用的 怀孕，但不提供持续的违规行为。严格的数据允许使用内存设备 （iuds）作为EC和持续的避孕措施，但EC使用ETONOGESTERL（ENG）植入物的EC效率数据， 缺乏。 CDC选定的避孕练习建议使用ENG的支持启动 植入if口服左甲虫（LNG）伴随的EC给出。该建议缺乏支持 证据并用作方法开始的障碍，因为诊所通常不提供口服LNG 客户想要植入物。此外，口服LNG效率在较高的体重指数（BMI）用户和 BMI在共同管理口服LNG和ENG植入物效率方面的作用尚不清楚。作为工程 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，它可以合理地使用 作为独立的EC或通过共同给药提高口服LNG的效率。而且，EC机制 与口服EC相关的作用与口服EC相关的作用，如果植入物使用或 没有口服液化天然气，会影响中周期使用者的效率。这项研究解决了以下研究差距 围绕使用ENG植入物作为EC的使用，这是提供这些选择提供者舒适的障碍：放松 在有或没有口服LNG的情况下，BMI的效率差异以及有或没有口服LNG的排卵频率。 我们提出了一项随机，安慰剂对照的非效率研究，以确定单独植入物是否不是 使用3.5％的非效率边距，比ENG植入物 +口服LNG更糟糕。我们将包括客户 谁出席了犹他州诊所的计划生育协会，并在72范围内提供了未受保护的性交的报告 想要EC的几个小时。有资格的EC客户对接受妊娠测试负面植入物感兴趣的客户将是 分配给研究组的1：1：（1）Eng植入物 +口服LNG或（2）Eng植入物 +安慰剂。我们的经验 研究人员将与参与者一起以4周的效率数据作为主要结果。我们的目标包括： （1）将ENG植入物 +口服LNG的效率与EN植入物的效率与790的EC进行比较 植入后四周通过怀孕状况评估的参与者（2）比较怀孕风险 由BMI类别（我们预计790名参与者中有一半将具有BMI≥25）。 植入物 +口服LNG和ENG植入物 +安慰剂组，以及（3）评估排卵频率在5 在202名参与者中插入ENG植入物 +口服LNG或Eng植入物 +安慰剂的日子 （月经后第7-14天）在通过血清孕激素水平和尿液生育监测仪评估时入学时 结果。我们的短期目标是扩大有或没有口服LNG的植入物发起效率的证据 满足EC客户的需求。我们的长期目标是制定基于证据的临床准则 为全球避孕措施提供信息，允许在EC时进行LARC咨询的公平，并支持 供人们实现其人生目标的生殖自主权。