Nexplanon Extension Trial

Nexplanon Extension TrialStudy of MK-8415/Etonogestrel Implant (Nexplanon) Use 36-60 Months Post-Insertion

An etonogestrel implant is a long-acting, reversible, hormonal birth control that is available for women by prescription. The rest of this letter has details about this trial. If you are interested in joining this clinical trial or have questions about it, please contact us using the information at the end of this letter.

Why is this clinical trial being done?
The etonogestrel implant is approved for use to prevent pregnancies for up to 3 years. It has not been approved to use for more than 3 years. The purpose of this clinical trial is to find out if using the implant for more than 3 years:

  • Is safe
  • Continues to prevent pregnancy
  • Affects the menstrual cycle (periods)
  • Causes problems when it is removed

Who can join this clinical trial?

You may be able to join this clinical trial if you:

  • Have an etonogestrel implant that was inserted 34–36 months ago (about 3 years ago)
  • Are willing to continue to use the etonogestrel implant for an additional 24 months and do not intend to use any other form of contraception (for example, condoms)
  • Are between 18 and 35 years old
  • Are able to get pregnant

There may be reasons why you cannot be in this clinical trial. The trial doctor or staff will discuss these with you.

Being part of this clinical trial is voluntary.
If the trial doctor decides you fit the criteria for this trial, you may choose to join the trial or not. If you choose to be part of the trial, you can change your mind and leave the trial at any time. This will not affect care you receive outside of the trial or any medical benefits that you had before starting the trial.

What will I be asked to do if I join?
If you join, you will be in the trial for about 27 months (a little over 2 years). You will:

  • Visit the trial site 11 times for the trial doctor and staff to check on your health and collect information for research purposes
  • Complete some trial-related activities between visits to the trial site, such as using an electronic diary (eDiary) to answer questions daily

You will be compensated after each study visit as well as for completing your e-diary every month. By completing the study you may receive a total compensation of up to $1380.

You will not be given a trial drug or treatment. This trial is researching the implant you already have.

Want more information about this study? Call the BEACON Research Team at 617-383-3500 or email us at dg-infofp@bmc.org.