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NCT02280109 · ClinicalTrials.gov registry record · Early Phase 1
Comparison of Tenofovir Vaginal Gel and Film Formulations
A Early Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT02280109: Completed Early Phase 1 study, sponsored by CONRAD.
NCT02280109 is a Early Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02280109, a Early Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is an open label comparative study of tenofovir gel and film in 10 healthy sexually active women without active female genital tract disorders. The women will receive a single dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and tenofovir film (1.3%;40 mg) - in a crossover study design to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid (primary objective).
Primary Outcome
Concentration-time plot of plasma tenofovir
Interventions
- DRUG Tenofovir Gel
- DRUG Tenofovir Film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-11 |
| Phase | Early Phase 1 |
What the finished NCT02280109 record still lists
NCT02280109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Tenofovir Gel is the first listed.
NCT02280109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02280109 about?
NCT02280109 is a clinical study titled "Comparison of Tenofovir Vaginal Gel and Film Formulations". This is an open label comparative study of tenofovir gel and film in 10 healthy sexually active women without active female genital tract disorders. The women will receive a single dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and tenofovir film (1.3%;40 mg) - in ...
What is the current status of trial NCT02280109?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2014-11.
What interventions are being tested in trial NCT02280109?
The interventions under investigation include: Tenofovir Gel (DRUG), Tenofovir Film (DRUG).
Who is sponsoring clinical trial NCT02280109?
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 NCT02280109's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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