Effectiveness of Prolonged Use of IUD/Implant for Contraception



Status:Active, not recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:3/2/2019
Start Date:December 2011
End Date:December 2022

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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.

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.

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
We found this trial at
2
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Jeffrey F Peipert, MD PhD
Phone: 317-948-0796
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Saint Louis, Missouri 63110
Principal Investigator: Colleen McNicholas, MD
Phone: 314-362-4317
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Saint Louis, MO
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