Clinical trial NCT02267616: Effectiveness of Prolonged Use of IUD/Implant for Contraception
Official title: Effectiveness of Prolonged Use of IUD/Implant for Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Levonorgestrel intrauterine device (LNG IUD)
Etonogestrel (ENG) Implant
Contraception
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Susan Thompson Buffett Foundation
First posted: 2014-10-17
Enrollment: 1076
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness
timeFrame: Three years
Secondary outcomes:
measure: Unintended pregnancy rates
timeFrame: Three years
measure: Time to contraceptive failure
timeFrame: Three years
measure: Randomized trial analysis
timeFrame: Three years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Saint Louis
country: United States
facility: Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Indiana University
name: Jeffrey F Peipert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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