Rifampin and the Contraceptive Implant

NCT04463680 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 19-2829
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 impacts on women and society. Rifampin is also a Class C medication for pregnancy and could have potential negative effects on a developing fetus. Additionally, women considering rifampin for treatment of LTBI face additional risks with an unintended pregnancy, making the reliability of contraception even more important for these women. The results of this study can directly inform counseling on a national and international basis for women who use the contraceptive implant and are considering their treatment options for LTBI.

Conditions

Contraception; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Serum Etonogestrel Concentrations

  Blood drawn before and after rifampin administration (2 weeks) for serum extraction and etonogestrel analysis

  2 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Will receive 2 week regimen of rifampin 600mg per day

Drug: Rifampin 600 MG

Interventions

Rifampin 600 MG DRUG

Administered daily for 2 weeks

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Aaron Lazorwitz
• Organization: University of Colorado Anschutz Medical Campus

aaron.lazorwitz@cuanschutz.edu

3037242019

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: September 23, 2020
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: May 16, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)