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)，通常在最近无保护措施的性行为后使用，以避免不受欢迎的情况 怀孕，但不提供持续的避孕措施。严格的数据允许使用宫内节育器 (宫内节育器)作为EC和正在进行的避孕，但EC关于使用依托诺孕酮(ENG)植入物的疗效数据， 是缺乏的。美国疾病控制与预防中心选择了避孕用法建议，以支持ENG的启动 如果EC同时口服左旋诺孕酮(LNG)，则植入。这项建议缺乏支持。 证据，并成为方法启动的障碍，因为在以下情况下，口服LNG通常不能在临床上获得 客户想要植入。此外，口服LNG的功效在较高体重指数(BMI)使用者和 BMI对联合口服LNG和ENG植入物的疗效的作用尚不清楚。作为ENG 植入物也是一种合成的孕激素，具有快速上升和一致的全身水平，它可能看似 作为单独的EC或与联合给药增加口服LNG的疗效。此外，欧盟委员会的机制 与口服EC抑制排卵有关的作用可能不同，如果植入是用或 没有口服LNG，影响中期周期使用者的疗效。这项研究解决了以下研究空白 对于EC来说，ENG植入物的使用是让提供者对以下选项感到满意的障碍：有效性 口服和不口服LNG的疗效通过体重指数、排卵频率以及口服和不口服LNG进行比较。 我们提出了一项随机、安慰剂对照、非劣势的研究，以确定ENG植入物是否单独没有 对于EC，比ENG植入物+口服LNG更差，使用3.5%的非劣势边际。我们将包括客户 世卫组织向犹他州计划生育协会诊所提交了72天内无保护性行为的报告 想要EC的人。符合条件的EC客户对妊娠测试阴性的植入物感兴趣的将是 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。我们经验丰富的 研究人员将对参与者进行跟踪，以获得4周的疗效数据作为主要结果。我们的目标包括： (1)比较ENG植入物+口服LNG与ENG植入物+安慰剂治疗790例EC的疗效。 受试者在植入种植体四周后根据怀孕情况进行评估，(2)比较怀孕风险 根据体重指数类别(我们预计790名参与者中有一半的人的体重指数≥为25)在眼科和眼科医院之间 植入物+口服LNG组和ENG植入物+安慰剂组，(3)评估排卵频率在5 202名周期中期参与者植入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)在入选时通过血孕酮水平和尿生育监测进行评估 结果。我们的短期目标是扩大使用或不使用口服LNG启动种植体的有效性的证据。 满足EC客户的需求。我们的长期目标是开发基于证据的临床指南，以 告知全球避孕实践，允许在欧共体期间公平地提供LARC咨询，并提供支持 生殖自主是人们实现其人生目标的重要途径。