Effectiveness of Prolonged Use of IUD/Implant for Contraception (EPIC)

April 12, 2021 updated by: Jeffrey Peipert, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1076

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continued Use Implant Group
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.
Device: Etonogestrel Implant
Subdermal arm implant
Active Comparator: New Implant Group
Woman randomly assigned to the new Etonogestrel Implant will have their existing Etonogestrel Implant removed and a new implant placed.
Device: Etonogestrel Implant
Subdermal arm implant
No Intervention: Observational Continued Use Group
Women who refuse randomization will have an option of continuing to use their existing Etonogestrel Implant beyond the FDA-approved duration (36 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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.
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unintended pregnancy rates
Time Frame: 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.
Three years
Time to contraceptive failure
Time Frame: 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).
Three years
Randomized trial analysis
Time Frame: 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).
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Susan Thompson Buffett Foundation

Investigators

  • Principal Investigator: Jeffrey F Peipert, MD, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1603304047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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