Effectiveness of Prolonged Use of IUD/Implant for Contraception

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Device: Etonogestrel Implant

• Registration Number: NCT02267616
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Status Verified: 2021-02
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1076

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Implant Group	Etonogestrel Implant	Woman randomly assigned to the new Etonogestrel Implant will have their existing Etonogestrel Implant removed and a new implant placed.
Continued Use Implant Group	Etonogestrel Implant	Woman randomly assigned to the continued use of their Etonogestrel Implant will continue to use their Etonogestrel Implant for contraception past FDA-approved duration of 36 months.

Primary Outcome Measures

Name	Time	Method
Effectiveness	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.

Secondary Outcome Measures

Name	Time	Method
Time to contraceptive failure	Three years	we will use Kaplan-Meier curves to describe the distribution of time to contraceptive failure for the LNG-IUD and ENG implant users compared to combined hormonal contraceptive users (control).
Randomized trial analysis	Three years	An identical analysis will be performed using the "intention-to-treat" principle (i.e. analyze the participant according to the assigned group as determined by randomization).
Unintended pregnancy rates	Three years	The contraceptive failure (unintended pregnancy) rates for the LNG-IUD and ENG implant users at 12, 24, and 36 months (after FDA-approved duration of use: 5 years for LNG IUD and 3 years for the ENG implant) of the contraceptive method will be compared to those for CHC users.

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Washington University in St. Louis School of Medicine; 🇺🇸 Saint Louis, Missouri, United States