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Label indication VANDAZOLE ® is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females. VANDAZOLE is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in post-menarchal females. ( 1 ) FDA label
Also known as MetroGel-Vaginal®
Metronidazole · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA) |
| 2 | ACTIVE_COMPARATOR | MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals) |
| Name | Type | Description |
|---|---|---|
| Metronidazole | DRUG | Vaginal Gel, 0.75% |
Inclusion Criteria: * Subjects must provide written informed consent prior to any study related procedures being performed. * Female subjects must have a clinical diagnosis of bacterial vaginosis, defined as having the presence of "clue cells" \> 20% of the total epithelia cells on microscopic exam...
Metronidazole is being studied for the treatment of bacterial vaginosis, a common vaginal infection. The clinical program described here focuses on a 0.75% metronidazole gel formulation. Bacterial vaginosis is the only indication listed for this asset, and the therapeutic area is infectious disease.
Teva Pharmaceutical Industries Limited is the developer of this metronidazole asset, and the company trades under the ticker TEVA. Teva is running the clinical program for the 0.75% metronidazole gel in bacterial vaginosis. The asset is a small molecule drug.
This metronidazole gel program is in Phase 1. The single listed trial, NCT01020396, is a Phase 1 study that has been completed. Metronidazole in this program is investigational and is not described as approved for bacterial vaginosis. No active trials are currently listed.
One trial is listed: NCT01020396, titled Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis. It was a Phase 1, randomized, double-blind, active-controlled study that enrolled 579 participants in the United States. Participants were female and at least 18 years old, and the trial is completed.
NCT01020396 was designed as a bioequivalence study of metronidazole gel, 0.75% in bacterial vaginosis. It used a randomized, double-blind, active-controlled design with 579 enrolled participants across sites in the United States. The study is listed as completed and was restricted to female participants aged 18 years and older.