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NCT02028338 · ClinicalTrials.gov registry record · Phase 2
Study of Dapivirine Vaginal Ring (VR) in Adolescents
A Phase 2 study, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT02028338: Completed Phase 2 study, sponsored by International Partnership for Microbicides.
NCT02028338 is a Phase 2 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02028338, a Phase 2 study, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study Summary
To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.
Primary Outcome
Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP. Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).
Interventions
- COMBINATION_PRODUCT placebo ring
- COMBINATION_PRODUCT dapivirine ring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2014-06-27 |
| Est. Completion | 2018-06-08 |
| Phase | Phase 2 |
What the finished NCT02028338 record still lists
NCT02028338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo ring is the first listed.
NCT02028338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02028338 about?
NCT02028338 is a clinical study titled "Study of Dapivirine Vaginal Ring (VR) in Adolescents". To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.
What is the current status of trial NCT02028338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2014-06-27. Estimated completion is 2018-06-08.
What interventions are being tested in trial NCT02028338?
The interventions under investigation include: placebo ring (COMBINATION_PRODUCT), dapivirine ring (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT02028338?
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 NCT02028338's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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