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COMPLETED Phase 3

Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis

NCT03091777 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 871 participants
Start Date 2017-03-10
Est. Completion 2018-03-27
Phase Phase 3

Sponsor

Balmoral Medical company

2 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 871 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Balmoral Medical company, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03091777 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03091777?

The interventions under investigation include: Placebo (DRUG), GDC-229 (DRUG), Metronidazole Vaginal Gel 0.75% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03091777?

This trial is sponsored by Balmoral Medical company, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial