NCT03091777

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 871 (actual)
• Sponsor: Balmoral Medical company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-03-10
• Primary completion: 2017-11-15
• Completion: 2018-03-27
• First posted: 2017-03-27
• Last updated: 2020-01-07
• Results posted: 2019-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study