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NCT01277640 · ClinicalTrials.gov registry record · Phase 1
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
A Phase 1 study, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01277640: Completed Phase 1 study, sponsored by International Partnership for Microbicides.
NCT01277640 is a Phase 1 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277640, a Phase 1 study, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.
Primary Outcome
Any evidence of Grade 2 or higher male genitourinary adverse event(s) as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009), Addendum 2 (Male Genital Toxicity Table for Use in Topical Microbicide Studies)
Interventions
- DRUG matched placebo
- DRUG dapivirine
- DRUG universal placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01277640 record still lists
NCT01277640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which matched placebo is the first listed.
NCT01277640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01277640 about?
NCT01277640 is a clinical study titled "Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures". The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.
What is the current status of trial NCT01277640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-03. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01277640?
The interventions under investigation include: matched placebo (DRUG), dapivirine (DRUG), universal placebo (DRUG).
Who is sponsoring clinical trial NCT01277640?
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 NCT01277640's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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