Status:
COMPLETED
Shoulder Contraceptive Implant Study
Lead Sponsor:
University of Colorado, Denver
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
This study will be the first to establish pharmacokinetic curves for the etonogestrel contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic data, the investigators...
Detailed Description
The etonogestrel contraceptive implant (Nexplanon®) remains the most effective hormonal contraceptive method available in the U.S. The contraceptive implant is routinely inserted just beneath the skin...
Eligibility Criteria
Inclusion
- Healthy women
Exclusion
- Any contraindications to etonogestrel implant use based on the US Medical Eligibility Criteria for Contraceptive use (defined as class 3 or 4 recommendation)18
- Any known liver conditions that could affect drug metabolism (e.g. cirrhosis, hepatitis)
- Currently taking any medications or supplements known to be CYP3A4 inducers/inhibitors19
- Body-mass index less than 18.5kg/m2 or greater than 30kg/m2
- Currently pregnant or planning to become pregnant in the next 12 months
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04463693
Start Date
October 14 2020
End Date
February 15 2022
Last Update
June 8 2023
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045