CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 871 enrolled
Drug / intervention
GDC-229 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03091777
NCT03091777Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Vehicle Controlled Study Evaluating the Therapeutic Equivalence and Safety of GDC-229 (Investigational Metronidazole 0.75% Vaginal Gel) and Metronidazole 0.75% Vaginal Gel in the Treatment of Bacterial Vaginosis

Balmoral Medical company·interventional·Posted Mar 27, 2017·Updated Jan 7, 2020

In Brief

A Phase 3 clinical trial evaluating GDC-229, Metronidazole Vaginal Gel 0.75%, and 1 other intervention for Bacterial Vaginosis. Completed, enrolled 871 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 27, 2017
Enrollment StartMar 10, 2017
Primary CompletionNov 15, 2017
Study CompletionMar 27, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.3 years ago

Interventions

GDC-229drug

GDC-229 is a vaginal gel.

Metronidazole Vaginal Gel 0.75%drug

Metronidazole Vaginal Gel 0.75% is an FDA-approved drug

Placebodrug

Inactive arm of the study