Status:
COMPLETED
Rifampin and the Contraceptive Implant
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Contraception
Tuberculosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
It is important for women taking rifampin to be aware if they are at greater risk of an unintended pregnancy while on the implant. An unintended pregnancy has many social, emotional, and financial imp...
Detailed Description
Rifampin is an antibiotic historically prescribed as part of a treatment regimen for active tuberculosis (TB) infection. Though active TB infections have become rarer over time in the US, it is estima...
Eligibility Criteria
Inclusion
- Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment and will maintain their implant during the study without modifications.
Exclusion
- o Women who are taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors.
- Women with a known allergy or insensitivity to rifampin.
- Women with a body mass index (BMI) \<18.5, as underweight women may have altered metabolism. The investigators will not have an upper BMI cut-off as studies have shown that overweight and obese women have equivalent metabolism and efficacy with the ENG contraceptive implant6,7.
- • Exclusions Criteria (screening laboratory testing)
- Women with any hepatic or renal dysfunction as determined by a comprehensive metabolic panel. For purposes of this study, liver function tests will be evaluated and evidence of hepatic dysfunction will be defined as an ALT \>52 or AST \>39, which are beyond the reference range of normal values used by the University of Colorado clinical laboratory. Renal function will be assessed by a serum creatinine and a value \>1.2 will be evidence of renal dysfunction as this is greater than the reference range used by the University of Colorado clinical laboratory.
- Women with any abnormal hematology as determined by a complete blood count. For purposes of this study, abnormal hematology will be defined as a WBC, RBC, or PLT value beyond the reference range of normal values used by the University of Colorado clinical laboratory.
- Women with abnormal coagulation factors as determined by coagulation factor tests (PT/INR, PTT). For purposes of this study, abnormal coagulation factors will be defined as any test value beyond the reference range of normal values used by the University of Colorado clinical laboratory.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04463680
Start Date
September 23 2020
End Date
February 22 2022
Last Update
May 16 2023
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045