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Not listed Early Phase 1 Interventional Accepts healthy volunteers

PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)

ClinicalTrials.gov ID: NCT03255915

Public ClinicalTrials.gov record NCT03255915. 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 Jul 23, 2026, 2:09 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

Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo

Study identification

NCT ID
NCT03255915
Recruitment status
Not listed
Study type
Interventional
Phase
Early Phase 1
Lead sponsor
Oak Crest Institute of Science
Other
Enrollment
15 participants

Conditions and interventions

Conditions

Interventions

  • Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

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

Study timeline

Start date
Sep 19, 2018
Primary completion
Sep 29, 2020
Completion
Dec 30, 2025
Last update posted
Nov 2, 2023

2018 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Texas Medical Branch Galveston Texas 77555

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03255915, 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 Nov 2, 2023 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03255915 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →