Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
Public ClinicalTrials.gov record NCT01020396. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01020396
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 579 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2001
- Primary completion
- Feb 28, 2003
- Completion
- Feb 28, 2003
- Last update posted
- Aug 18, 2024
2002 – 2003
United States locations
- U.S. sites
- 37
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinic for Women, PA | Huntsville | Alabama | 35801 | — |
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | — |
| Edinger Medical Group | Fountain Valley | California | 92708 | — |
| Office of Drs. Shepard and Lugerner, PC | Washington D.C. | District of Columbia | 20006 | — |
| Meadowcrest Women's Center | Crystal River | Florida | 34429 | — |
| Florida Medical and Research Institute, PA | Gainesville | Florida | 32607 | — |
| The Florida Wellcare Alliance, LC | Inverness | Florida | 34452 | — |
| Wellness Center for Gyn & Osteoporosis | Inverness | Florida | 34452 | — |
| Florida Medical and Research Institute, PA | Ocala | Florida | 34471 | — |
| KGR, LLC | Riverdale | Georgia | 30274 | — |
| Women's Health Practice | Champaign | Illinois | 61820 | — |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | — |
| New Orleans Institute of Clinical Investigation | New Orleans | Louisiana | 70112 | — |
| Phoenix Ob-Gyn Associated | Moorestown | New Jersey | 08057 | — |
| Phoenix Ob-Gyn Associates | Mount Holly | New Jersey | 08060 | — |
| Kings County Hospital Center | Brooklyn | New York | 11203 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Chapel Hill Obstetrics and Gynecology, PA | Chapel Hill | North Carolina | 27514 | — |
| Cooperfield Obstetrics and Gynecology, LLC | Concord | North Carolina | 28025 | — |
| O.U. Physicians' Building | Oklahoma City | Oklahoma | 73104 | — |
| The OU Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| University of Oklahoma Health Services Center | Oklahoma City | Oklahoma | 73104 | — |
| Medford Women's Clinic | Medford | Oregon | 97504 | — |
| Philadelphia Women's Research | Philadelphia | Pennsylvania | 19114 | — |
| Elite Medical Research, Inc. | Sellersville | Pennsylvania | 18960 | — |
| Stonebridge OB/GYN Associates | Sellersville | Pennsylvania | 18960 | — |
| Anderson Family Care | Anderson | South Carolina | 29621 | — |
| Carolina OB/GYN | Anderson | South Carolina | 29621 | — |
| Primary Care Associates | Anderson | South Carolina | 29621 | — |
| Radiant Research | Anderson | South Carolina | 29621 | — |
| Research Memphis | Memphis | Tennessee | 38116 | — |
| Millennium Clinical Research Center, LLC | Arlington | Virginia | 22203 | — |
| Women's Health Associates, PC | Fairfax | Virginia | 22031 | — |
| Office of H. Sharon Sethi | Fairfax | Virginia | 22033 | — |
| MedSource, Inc. | Richmond | Virginia | 23229 | — |
| Office of Max S. Maizels, MD | Richmond | Virginia | 23229 | — |
| Office of Prescott W. Prillaman, MD, PC | Richmond | Virginia | 23229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01020396, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2024 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01020396 live on ClinicalTrials.gov.