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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 is a Early Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 10 participants.
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).
Interventions
- DRUG Tenofovir Gel
- DRUG Tenofovir Film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02280109
The ClinicalTrials.gov registry entry for NCT02280109 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 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 2 interventions - of which Tenofovir Gel is the first listed.
NCT02280109 reports 0 study locations.
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.
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