Clinical Research Details

Clinical Research

A Phase 3, Open-Label, Multicenter, Single Arm Study to assess contraceptive efficacy and safety of the Etonogestrel (MK-8415) Implant during extended use from 3 years after insertion in females 35 years of age or younger

Study Description

The etonogestrel implant is approved for use to prevent pregnancies for up to 3-years. It has not been approved for more than 3-years. The use of the etonogestrel implant in this trial for more than 3-years is investigational.

We are looking for healthy female volunteers ages 18-35 who are approaching their 3-year mark of having their Nexplanon Implant inserted to see if they would like to keep their current Nexplanon in place for 24 more months.

You can be in this study if you have had an etonogestrel implant for at least 36 months.

Participants need to be currently sexually active with a male partner.

You must be 35 years old or younger and able to become pregnant.

You will be in the trial for up to about 27 months and will visit the trial site about 11 times.

There may be reasons why you cannot be in this trial. The trial doctor or trial staff will discuss this with you. About 450 people will be in this trial.

Required procedures include: Blood work, physical exam, pap smear, vaginal swabs, urinalysis, and palpation of your implant.

Eligible participants are compensated for participation.

Open Enrollment

Contact Name: Melanie Schafer
Contact Phone: (904) 633-0066
Contact Email: melanie.schafer@jax.ufl.edu

Investigators


Principal Investigator
Andrew M. Kaunitz, M.D., FACOG
Obstetrics and Gynecology

Sub Investigator
Courtney P. Rhoades, D.O., M.B.A.
Obstetrics and Gynecology