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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03819114

Public ClinicalTrials.gov record NCT03819114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 5:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03819114
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
122 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 6, 2019 (Actual)
Primary completion
Nov 2, 2020 (Actual)
Completion
Nov 30, 2020 (Actual)
Last update posted
Dec 27, 2021

2019 – 2020

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
2701 Northwestern University CRS Chicago Illinois 60611 —
Rush Univ. Med. Ctr. ACTG CRS (2702) Chicago Illinois 60612 —
Weill Cornell Upton CRS (7803) New York New York 10065 —
Unc Aids Crs (3201) Chapel Hill North Carolina 27514 —
Hosp. of the Univ. of Pennsylvania CRS (6201) Philadelphia Pennsylvania 19104 —
Pitt CRS (1001) Pittsburgh Pennsylvania 15213 —
Trinity Health and Wellness Center CRS (31443) Dallas Texas 75208 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03819114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 27, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03819114 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →