Effectiveness of Prolonged Use of IUD/Implant for Contraception

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Prolonged Use of IUD/Implant for Contraception

Conditions
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Contraception

Intervention / Treatment
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* Device: Etonogestrel Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will evaluate the use of the Etonogestrel Implant or hormonal intrauterine device (IUD) for contraception past the FDA approved duration. The Etonogestrel Implant is currently approved for 3 years of use, and the hormonal IUD is currently approved for 5 years.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continued Use Implant Group<br>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<br>* Subdermal arm implant<br>|
| Active Comparator: New Implant Group<br>Woman randomly assigned to the new Etonogestrel Implant will have their existing Etonogestrel Implant removed and a new implant placed. | Device: Etonogestrel Implant<br>* Subdermal arm implant<br>|
| No Intervention: Observational Continued Use Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levonorgestrel intrauterine device (LNG IUD), Etonogestrel (ENG) Implant, Contraception