Status:
COMPLETED
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Merck Sharp & Dohme LLC
University of Colorado, Denver
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception
Exclusion
- 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.
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04423055
Start Date
August 13 2020
End Date
April 9 2024
Last Update
May 22 2024
Active Locations (3)
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1
University of California, Davis
Sacramento, California, United States, 95817
2
University of Colorado
Denver, Colorado, United States, 80045
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104