NexTOC2: Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive

NexTOC2: Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive

Brief description of study

Women currently using or starting a combined oral contraceptive (COC) will be offered study enrollment. Study subjects will have a Nexplanon placed and followed for approximately 12 months to evaluate if they continue the implant, the COC, or both, and to assess bleeding patterns and adverse events.

Detailed description of study

Description
This is a study to see if women who are using or plan to use a birth control pill as their main method of birth control are willing to use a hormonal birth control implant at the same time to better prevent pregnancy. Participants will use the birth control pills as their main method of birth control and have the implant as a continuous back-up method.
The pill and the implant are both currently FDA-approved to use as birth control. The implant, known as Nexplanon, is a small, flexible, plastic rod, about the size of a matchstick that is placed under your skin in your upper arm. It releases a small amount of hormone every day and is the most effective form of hormonal contraception.
The study provides the implant but does not provide birth control pills. If you do not have a prescription for your birth control pills already, you will need to see a doctor either at our clinic or another clinic and obtain the prescription before we can see you for the study. We can help you with an appointment if you need one.
This study is occurring at 3 centers across the U.S. Approximately 40 participants will be enrolled in this study at the University of Pennsylvania.

This Study Requires
Women in the study will have 4 visits during the 12 months of the study:
  • The first visit is a screening and enrollment visit. We will determine if you are eligible to take part in the study. This visit will include the consent, medical history and birth control implant placement. If you decide you want to come back to have the implant placed on a different day, we can make that arrangement. After the implant is placed, you will be given diaries to complete once a day and return them at your follow up visits.
  • You will have follow-up visits at the research office about 3, 6 and 12 months after the implant is placed. At these visits, we will collect your diaries, see if you’ve had any problems, and discuss your satisfaction with your birth control methods.
During the study, you can ask to have the implant removed if you don’t want to keep using it. You can also stop using your birth control pill if you want to. It is all up to you. For this study, we want to follow you for a full 12 months no matter if you choose to stop using either the pill or the implant.
At the end of the 12 months, you can choose to continue to use the birth control implant after the study.

Compensation
You will receive up to $350 for your time and effort.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    healthy volunteer,Combined Oral Contraceptive in women,healthy volunteer,healthy volunteer
  • Age: Between 18 Years - 65 Years
  • Gender: Female

  • Women 18 years and older
  • Currently using birth control pills or have a birth control pill prescription and intending to start taking them for birth control

Updated on 20 Apr 2023. Study ID: 843509

Interested in the study

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