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NCT01369303 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel

A Phase 1 study, sponsored by CONRAD.

Completed
Registry status
Phase 1
Development phase
194
Enrollment target

NCT01369303 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 194 participants.

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The verdict

NCT01369303, a Phase 1 study, has completed, sponsored by CONRAD.

COMPLETED
Registry status
Phase 1
Development phase
194 participants
Enrollment target

Study Summary

The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex acts.

Interventions

  • DRUG Tenofovir 1% vaginal gel

Trial Details

FieldValue
Enrollment Target 194 participants
Start Date 2012-01
Est. Completion 2013-05
Phase Phase 1

Sponsor

CONRAD

33 total trials

What the Registry Record Tells You About NCT01369303

The ClinicalTrials.gov registry entry for NCT01369303 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CONRAD, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Tenofovir 1% vaginal gel is the first listed.

NCT01369303 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01369303 about?

NCT01369303 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel". The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex acts.

What is the current status of trial NCT01369303?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 194 participants. The study started on 2012-01. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01369303?

The interventions under investigation include: Tenofovir 1% vaginal gel (DRUG).

Who is sponsoring clinical trial NCT01369303?

This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.