- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423055
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive (NextOC2)
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted at three sites across the United States: University of California, Davis, University of Colorado and University of Pennsylvania. Investigators will recruit women currently using COCs or intending to initiate COCs for pregnancy prevention. Each site will recruit approximately 40 women for a total of 120 subjects.
Visit 1:
Informed consent will be obtained. As part of informed consent, subjects will be educated that there is little data available on the adverse effects of combined COC and ENG implant use. The consent form will include a standardized description of the side effects and bleeding profile of COCs and the implant. Subjects will also need to review the package label information for Nexplanon and sign the FDA-required Nexplanon consent. After obtaining informed consent, subjects will be screened for entry criteria. Medical history will be obtained. A urine pregnancy test will be performed. Eligible subjects will have a Nexplanon contraceptive implant placed. A diary will be dispensed for the subject to document daily bleeding, COC use and adverse events.
Follow-up:
Follow up contact will be at approximately 4, 12, 26 and 39 weeks with the exit visit scheduled at 52 weeks.
At each follow up contact, the diary will be reviewed. Adverse events will be determined by inquiry and diary review. The subject will inform the study staff if she is using her COC and if she wants to continue use of her COC and ENG implant. The ENG implant will be removed upon request at any time during the study.
Study participation will be complete after the 52 week (~ 12 month) exit visit.
No blood draws will occur during this study.
A diary will be used but no surveys will be used.
Data to be collected by study staff include demographics, past medical and gynecologic history, prior and current contraceptive use.
Because women are being enrolled who are already currently using COCs or who plan to start COCs, the COC is not a study drug. The study intervention (study drug) is the contraceptive implant. The systemic hormone exposure with a contraceptive implant is minimal relative to a COC. The investigators do not expect any increase in side effects by adding a contraceptive implant to COC users. Of note, the primary risk with COC use is related to the estrogen which can increase the risk of venous thromboembolic disease. The implant has no estrogen. All products being used in the study are FDA-approved for contraception.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California, Davis
-
-
Colorado
-
Denver, Colorado, United States, 80045
- University of Colorado
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception
Exclusion Criteria:
- Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical Eligibility Criteria [MEC])
- Because the CDC MEC are continuously revised, the most updated criteria will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm)
- Women who are currently participating in a clinical trial or have participated within the past 30 days.
- Less than 2 weeks from the end of a pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COC users or new starts
Subjects will have an etonogestrel contraceptive implant placed at enrollment.
Women using COC as method of contraception for at least 1 month will be considered COC users.
Women using COC for less than 1 month will be considered new starts.
|
Place etonogestrel contraceptive implant.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Evaluating ENG Implant as Acceptable
Time Frame: 52 weeks
|
Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Evaluating ENG as Tolerable: Tolerability
Time Frame: 52 weeks
|
Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception
|
52 weeks
|
Number of Participants Continuing COC
Time Frame: 52 weeks
|
Continuation of COC over 52 weeks of evaluation regardless of whether or not the implant was still present at 52 weeks
|
52 weeks
|
Bleeding Patterns
Time Frame: 52 weeks
|
Bleeding patterns while using a COC concomitantly with ENG implant
|
52 weeks
|
Post-study Method Plan
Time Frame: 52 weeks
|
Plan to continue the COC and/or implant after the study based on interview at last visit
|
52 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melissa C Matulich, MD MAS, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1571368
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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