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临床试验/NCT02267616
NCT02267616已完成不适用

Effectiveness of Prolonged Use of IUD/Implant for Contraception

Indiana University4 个研究点 分布在 1 个国家目标入组 1,076 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,076
试验地点
4
主要终点
Effectiveness

研究概览

简要总结

This study will evaluate LNG-IUD and Etonogestrel (ENG) Implant users who are willing to use their contraception beyond the end of the FDA-approved duration. ENG Implant users will also be offered to participate in an arm of the study that will randomize them to either keeping their implant in or having it removed and replaced with a new implant. Participants will be followed for up to three years.

详细描述

This prospective cohort study will evaluate 675 LNG-IUD users and 675 Etonogestrel (ENG) Implant users who are within 6 months of expiration or beyond the end of the FDA-approved duration. Participants will be contacted via telephone and either scheduled to enroll in person or be mailed the consent form before participation in the EPIC study. After the signed consent form is obtained, participants will also be asked to complete a brief telephone or in-person questionnaire on sociodemographic, medical and reproductive history, sexual and contraceptive history, history of unintended pregnancy and substance abuse. During the informed consent process, implant users will also be offered to participate in an arm of the study that will randomize them (if they consent) to either keeping their subdermal implant in or have it removed and replaced with a new subdermal implant. The randomized control trial subset allows us to compare effectiveness to that of a new implant.

It also allows us to assess "other contraceptive use" (e.g. condom use) in both groups.

Participants will also be asked if they are interested in providing a blood sample for analysis of etonogestrel assay levels at baseline enrollment and annually. If Follow-up phone interviews will occur every 6 months for 36 months beyond the expiration of their method. The investigators will attempt to validate all pregnancy outcomes with medical chart reviews.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age 18-45
  • Within 6 months of expiration or beyond the end of the FDA-approved duration of use of the levonorgestrel intrauterine device (LNG-IUD = 5 years) OR the etonogestrel-releasing subdermal implant (ENG implant = 3 years)
  • Able to consent in English or Spanish.
  • Not pregnant at the time of enrollment

排除标准

  • Have history of female sterilization procedure
  • Desire for conception in the next 12 months
  • Not sexually active with a male partner

结局指标

主要结局

Effectiveness

时间窗: Three years

Our primary aim is to test the absolute and relative effectiveness of both the LNG-IUD and the ENG implant in a non-inferiority (equivalence) study comparing failure rates of these methods in the 3 years post-FDA approved duration to the failure rates during the first three years.

次要结局

  • Time to contraceptive failure(Three years)
  • Randomized trial analysis(Three years)
  • Unintended pregnancy rates(Three years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Peipert

The Clarence E. Ehrlich Professor; Chair, Dept of Obstetrics and Gynecology

Indiana University

研究点 (4)

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