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VeraCept- Intrauterine Device (IUD) for Birth Control - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the VeraCept Intrauterine Device (IUD) protects against pregnancy as well as other similar IUDs.

This type of intrauterine contraceptive is similar to the FDA approved ParaGard® (Copper) IUD.

What is the Condition Being Studied?

Intrauterine Device (IUD) for Birth Control

Who Can Participate in the Study?

Woman who:
- Can get pregnant
- Are 18 to 35 years years of age
- Are interested in using an intrauterine device (IUD) for birth control for up to 5 years
- Are in a mutually monogamous relationship of at least 3 months duration
- Are willing to use this IUD as your only method of birth control

Age Group
Adults

What is Involved?

If you agree to join this study, you will:
- Have a screening visit to see if you can join the study
-- During this visit, you will have:
--- A pregnancy test
--- Infectious disease testing
--- PAP smear (if you have not had one recently),
--- A pelvic exam

- After the screening visit, you will:
-- Have the VeraCept IUD inserted at the same visit
OR
-- Be asked to return for another visit to have the VeraCept IUD inserted

- Be followed up to 5 years once it is inserted or until the VeraCept IUD is removed
- Have 14 scheduled in-person study visits during this study
- Be asked to complete a daily e-diary and other phone call visits from the study team

Study Details

Full Title
A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept?, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability
Principal Investigator
Obstetrician and Gynecologist
Protocol Number
IRB:PRO00092238
NCT:NCT03633799
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698