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NCT02209519 · ClinicalTrials.gov registry record · Phase 3
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
A Phase 3 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT02209519: Completed Phase 3 study, sponsored by University of Alabama at Birmingham.
NCT02209519 is a Phase 3 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02209519, a Phase 3 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with metronidazole or placebo to compare the rates of recurrent BV in the women
Primary Outcome
the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH \> 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score \>3 No Recurrence/Persistence is measured by: \- Presence of 0 -2 Amsel criteria; Nugent score 0-3.
Interventions
- DRUG Metronidazole (male partner)
- OTHER Placeob (male partner)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2015-02 |
| Est. Completion | 2019-03 |
| Phase | Phase 3 |
What the finished NCT02209519 record still lists
NCT02209519 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Metronidazole (male partner) is the first listed.
NCT02209519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02209519 about?
NCT02209519 is a clinical study titled "Randomized Controlled Trial of Treatment of Male Partners of Women With BV". Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with metronidazole or placebo to compare the rates of recurrent BV in the women
What is the current status of trial NCT02209519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2015-02. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02209519?
The interventions under investigation include: Metronidazole (male partner) (DRUG), Placeob (male partner) (OTHER).
Who is sponsoring clinical trial NCT02209519?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02209519's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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