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NCT03091777 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
A Phase 3 study of Bacterial Vaginosis, sponsored by Balmoral Medical company.
- Completed
- Registry status
- Phase 3
- Development phase
- 871
- Enrollment target
- 1
- Study location
NCT03091777: Completed Phase 3 study of Bacterial Vaginosis, sponsored by Balmoral Medical company.
NCT03091777 is a Phase 3 study of Bacterial Vaginosis that has completed, run by Balmoral Medical company. The registered enrollment target is 871 participants, above the 280-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (211% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03091777, a Phase 3 study of Bacterial Vaginosis, has completed, sponsored by Balmoral Medical company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 871 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.
Primary Outcome
Resolution of clinical signs and symptoms
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GDC-229
- DRUG Metronidazole Vaginal Gel 0.75%
Study Locations (1)
North Carolina
- Site 103 - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 871 participants |
| Start Date | 2017-03-10 |
| Est. Completion | 2018-03-27 |
| Phase | Phase 3 |
What the finished NCT03091777 record still lists
NCT03091777 is an interventional study that assigns participants to a tested intervention. The registered 871 participants enrollment target is mid-sized for trials with a published cap, above the 280-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (211% higher).
The record links to 1 condition, with Bacterial Vaginosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03091777 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03091777 about?
NCT03091777 is a clinical study titled "Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis". This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.
What is the current status of trial NCT03091777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 871 participants. The study started on 2017-03-10. Estimated completion is 2018-03-27.
What conditions does trial NCT03091777 study?
This clinical trial studies the following conditions: Bacterial Vaginosis.
What interventions are being tested in trial NCT03091777?
The interventions under investigation include: Placebo (DRUG), GDC-229 (DRUG), Metronidazole Vaginal Gel 0.75% (DRUG).
Who is sponsoring clinical trial NCT03091777?
This trial is sponsored by Balmoral Medical company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03091777 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bacterial Vaginosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03091777's enrollment target sits among peer trials
871 1st of 15 higher than 15 of 15 other Bacterial Vaginosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Vaginosis 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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