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NCT04463680

Rifampin and the Contraceptive Implant

Completed Phase 4 Results posted Last updated 16 May 2023
What this trial tests

Phase 4 trial testing Rifampin 600 MG in Contraception in 24 participants. Completed in 22 February 2022.

Timeline
23 September 2020
Primary endpoint
22 February 2022
22 February 2022

Quick facts

Lead sponsorUniversity of Colorado, Denver
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment24
Start date23 September 2020
Primary completion22 February 2022
Estimated completion22 February 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 45, female only, with Contraception or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Serum Etonogestrel Concentrations Primary · 2 weeks

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

Baseline
GroupValue95% CI
Rifampin 600 mg164.094.4 – 265.0
Post-rifampin
GroupValue95% CI
Rifampin 600 mg47.824.7 – 82.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The effect of rifampin on serum etonogestrel concentrations and biomarkers of ovulation among contraceptive implant users: A pharmacokinetic and pharmacodynamic study.
    Lazorwitz A, Sheeder J, Teal S. · · 2023 · cited 2× · PMID 36997081 · DOI 10.1016/j.contraception.2023.110035

Verify or expand the search:

Other recruiting trials for Contraception

Currently open trials in the same condition.

Other University of Colorado, Denver trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04463680.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing