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NCT01020396 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Teva Pharmaceuticals USA.

Completed
Registry status
Phase 1
Development phase
579
Enrollment target

NCT01020396: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.

NCT01020396 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 579 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01020396, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.

COMPLETED
Registry status
Phase 1
Development phase
579 participants
Enrollment target

Study 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.

Interventions

  • DRUG Metronidazole

Trial Details

FieldValue
Enrollment Target 579 participants
Start Date 2002-01
Est. Completion 2003-03
Phase Phase 1

Sponsor

Teva Pharmaceuticals USA

83 total trials

What the Registry Record Tells You About NCT01020396

The ClinicalTrials.gov registry entry for NCT01020396 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 579 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Pharmaceuticals USA, which has 83 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Metronidazole is the first listed.

NCT01020396 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01020396 about?

NCT01020396 is a clinical study titled "Bioequivalence of Metronidazole 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 treatme...

What is the current status of trial NCT01020396?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 579 participants. The study started on 2002-01. Estimated completion is 2003-03.

What interventions are being tested in trial NCT01020396?

The interventions under investigation include: Metronidazole (DRUG).

Who is sponsoring clinical trial NCT01020396?

This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.