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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要口服紧急避孕药（EC）通常在最近无保护性交后使用，以避免发生意外怀孕，但不提供持续避孕严格的数据允许使用宫内节育器。（宫内节育器）作为 EC 和持续避孕，但使用依托孕烯 (ENG) 植入物的 EC 疗效数据，缺乏 CDC 避孕药具选择实践建议支持 ENG 的启动。如果同时给予口服左炔诺孕酮 (LNG)，则需要植入植入物这缺乏支持的建议。证据并成为方法启动的障碍，因为在以下情况下，临床上通常不提供口服液化天然气：此外，体重指数 (BMI) 较高的使用者和口服 LNG 的疗效会降低。 BMI 对口服 LNG 和 ENG 植入联合给药的疗效的作用尚不清楚。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，它可以合理地发挥作用单独使用 EC 或与口服 LNG 联合给药可提高疗效。与口服 EC 排卵抑制相关的作用可能会有所不同，如果植入物是用或没有口服液化天然气，影响中期使用者的功效本研究解决了以下研究空白。围绕使用 ENG 植入物进行 EC，这些选项成为提供者舒适度的障碍：功效使用和不使用口服 LNG、BMI 的功效差异以及使用和不使用口服 LNG 的排卵频率。我们提出了一项随机、安慰剂对照、非劣效性研究，以确定单独的 ENG 植入是否没有效果。比 EC 的 ENG 植入 + 口服 LNG 差，使用 3.5% 的非劣效性裕度，我们将包括客户。向犹他州计划生育协会诊所提交 72 岁以内无保护性交报告的人对怀孕测试呈阴性的植入物感兴趣的合格 EC 客户将在 2 小时内进行。按 1:1 分配给研究组：(1) ENG 植入物 + 口服 LNG 或 (2) ENG 植入物 + 安慰剂。研究人员将对参与者进行为期 4 周的疗效数据跟踪，作为主要结果。 (1) 比较 ENG 植入物 + 口服 LNG 与 ENG 植入物 + 安慰剂对 790 例 EC 的疗效种植体植入后四周对参与者的妊娠状况进行评估，(2) 比较妊娠风险按 ENG 之间和内部的 BMI 类别（我们预计 790 名参与者中有一半的 BMI ≥25）植入物 + 口服 LNG 和 ENG 植入物 + 安慰剂组，以及 (3) 评估 5 天内的排卵频率 202 名周期中期参与者插入 ENG 植入物 + 口服 LNG 或 ENG 植入物 + 安慰剂的天数（月经后第 7-14 天）在入组时通过血清孕酮水平和尿液生育力监测仪进行评估我们的短期目标是扩大有关有或没有口服 LNG 的植入起始效果的证据。满足 EC 客户的需求是制定基于证据的临床指南。为全球避孕实践提供信息，在 EC 时实现 LARC 咨询的公平性，并提供支持人们实现生育目标的生殖自主权。