At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
Levonorgestrel (LNG)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Phase II Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jan 28, 2019·Updated Dec 27, 2021
In Brief
A Phase 2 clinical trial evaluating Levonorgestrel (LNG) for HIV Infections and Tuberculosis. Completed, enrolled 122 participants across 18 sites in 7 countries.
Detailed Summary
The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) 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 versus standard-dose (1.5 mg) was also compared.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Tuberculosis
CountriesBotswana, Brazil, Kenya, Malawi, South Africa, Thailand, United States
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartMay 2019
Primary CompletionNov 2020
Study CompletionNov 2020
TodayJul 2026
First PostedJan 28, 2019
Enrollment StartMay 6, 2019
Primary CompletionNov 2, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.4 years ago
Interventions
Levonorgestrel (LNG)drug
LNG tablet(s) were administered by mouth in a directly observed manner.