NCT01020396

Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis

A Multi-Center, Double-Blind, Parallel Group Study Comparing the Bioequivalence of Teva Pharmaceuticals, USA's Generic Formulation of Metronidazole Vaginal Gel, 0.75% and MetroGel-Vaginal® Metronidazole Vaginal Gel, 0.75% in the Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 579 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Metronidazole	Vaginal Gel, 0.75%
DRUG	Metronidazole	Vaginal Gel, 0.75%

Timeline

• Start date: 2002-01-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2009-11-25
• Last updated: 2024-08-19

Locations

37 sites across 1 country: United States