Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (865% higher). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2002-01 |
| Est. Completion | 2003-03 |
| Phase | Phase 1 |
What the finished NCT01020396 record still lists
NCT01020396 is an interventional study that assigns participants to a tested intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (865% higher).
The record links to 0 conditions, and to 1 intervention - of which Metronidazole is the first listed.
NCT01020396 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01020396's enrollment target sits among peer trials
579 32nd of 2000 higher than 1,969 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04575935 · 580 participants · Phase 3
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
- NCT05143177 · 580 participants · Phase 2
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
- NCT05696353 · 580 participants · Phase 3
Teen Driving Translation Study (NIH)
- NCT06578104 · 580 participants
PULSED AF Post-Approval Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia