Overview

Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy

Status:
Completed

Trial end date:
2020-11-30

Target enrollment:

Participant gender:

Summary

The purpose of this pharmacokinetic (PK) study is to evaluate if a double dose (3 mg) of levonorgestrel (LNG) emergency contraception (EC) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin (RIF)-containing tuberculosis (TB) therapy. The safety of double-dose (3.0 mg) LNG EC versus standard-dose (1.5 mg) will also be compared.

Phase:

Phase 2

Details

Lead Sponsor:

AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Anti-Retroviral Agents
Antitubercular Agents
Efavirenz
Levonorgestrel
Rifampin