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NCT03234400 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
A Phase 1 study, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT03234400: Completed Phase 1 study, sponsored by International Partnership for Microbicides.
NCT03234400 is a Phase 1 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03234400, a Phase 1 study, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
Primary Outcome
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Interventions
- COMBINATION_PRODUCT Dapivirine Vaginal Ring, 25 mg
- COMBINATION_PRODUCT Dapivirine Vaginal Ring, 100 mg
- COMBINATION_PRODUCT Dapivirine Vaginal Ring, 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2019-01-23 |
| Phase | Phase 1 |
What the finished NCT03234400 record still lists
NCT03234400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Dapivirine Vaginal Ring, 25 mg is the first listed.
NCT03234400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03234400 about?
NCT03234400 is a clinical study titled "A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings". Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
What is the current status of trial NCT03234400?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2017-12-04. Estimated completion is 2019-01-23.
What interventions are being tested in trial NCT03234400?
The interventions under investigation include: Dapivirine Vaginal Ring, 25 mg (COMBINATION_PRODUCT), Dapivirine Vaginal Ring, 100 mg (COMBINATION_PRODUCT), Dapivirine Vaginal Ring, 200 mg (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03234400?
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 NCT03234400's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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