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Effect of Rifampin on Etonogestrel Concentrations in Implant Users
NCT04463680Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2020
- Primary completion
- Feb 2022
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Small Molecules
- Drugs
- rifampicin
- Conditions
- Tuberculosis (TB)
01
Overview
Phase 4, open-label, single-arm trial of rifampicin in Tuberculosis (TB), sponsored by University of Colorado Denver. Primary endpoint: Serum Etonogestrel Concentrations at 2 weeks. Started Sep 2020; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Intervention
Participants receive Rifampin 600 mg daily for 2 weeks.
03
Who it enrols
Healthy women with an etonogestrel implant for 12-36 months, excluding those with BMI <18.5, hepatic/renal dysfunction, or use of CYP3A4 inducers/inhibitors.
04
Endpoints
Primary
Serum Etonogestrel Concentrations
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