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NCT01548560 · ClinicalTrials.gov registry record · Phase 1
Assessing the Safety of Dapivirine Gel and Film Formulations
A Phase 1 study, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01548560: Completed Phase 1 study, sponsored by International Partnership for Microbicides.
NCT01548560 is a Phase 1 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01548560, a Phase 1 study, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
Primary Outcome
The safety/toxicity endpoint is clinical or laboratory evidence of a Grade 2 or higher Adverse Event as defined by the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 and the Female Genital Grading Table for Use in Microbicide Studies which is judged to be related to study product.
Interventions
- DRUG Dapivirine Vaginal Film
- DRUG Dapivirine Vaginal Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01548560 record still lists
NCT01548560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Dapivirine Vaginal Film is the first listed.
NCT01548560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01548560 about?
NCT01548560 is a clinical study titled "Assessing the Safety of Dapivirine Gel and Film Formulations". This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
What is the current status of trial NCT01548560?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-08. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01548560?
The interventions under investigation include: Dapivirine Vaginal Film (DRUG), Dapivirine Vaginal Gel (DRUG).
Who is sponsoring clinical trial NCT01548560?
This trial is sponsored by International Partnership for Microbicides, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01548560's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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