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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03091777
The ClinicalTrials.gov registry entry for NCT03091777 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 871 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 280-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (211% higher). The listed sponsor is Balmoral Medical company, which has 4 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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