Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Teva Pharmaceuticals USA |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 579 |
| Start date | 2002-01 |
| Completion | 2003-03 |
Conditions
- Bacterial Vaginosis
Interventions
- Metronidazole
- Metronidazole
Primary outcomes
- Therapeutic cure rate of the subject at the Test-of-Cure Visit. — Visit 3
- Incidence of Adverse Effects reported throughout the study. — 29 Days
Countries
United States