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

NCT03091777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 871

Last updated 2020-01-07

Study results available
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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

  • Bacterial Vaginosis

Interventions

DRUG

GDC-229

GDC-229 is a vaginal gel.

DRUG

Metronidazole Vaginal Gel 0.75%

Metronidazole Vaginal Gel 0.75% is an FDA-approved drug

DRUG

Placebo

Inactive arm of the study

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Balmoral Medical company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2017-11-15
Completion
2018-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091777 on ClinicalTrials.gov