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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: Completed Phase 1 study, sponsored by CONRAD.
NCT01369303 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 194 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (223% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Each participant will be randomized to one of nine groups: (dosing regimen: BAT24, precoital or postcoital) x (sample collection time-point: 4, 12 or 72 hours after the single act of study-related sex). Approximately 30 women will be assigned to each dosing regimen.
Interventions
- DRUG Tenofovir 1% vaginal gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01369303 record still lists
NCT01369303 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (223% higher).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir 1% vaginal gel is the first listed.
NCT01369303 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369303's enrollment target sits among peer trials
194 282nd of 2000 higher than 1,719 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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