Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
NCT ID: NCT01020396
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
579 participants
INTERVENTIONAL
2002-01-31
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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1
Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)
Metronidazole
Vaginal Gel, 0.75%
2
MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)
Metronidazole
Vaginal Gel, 0.75%
Interventions
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Metronidazole
Vaginal Gel, 0.75%
Metronidazole
Vaginal Gel, 0.75%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 examination of a saline "wet mount" and all of the following criteria: Off-white (milky or grey), thin, homogeneous discharge; pH of vaginal fluid \> 4.7; a positive 10% KOH "whiff test".
* Subjects must be 18 years of age or older with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Women of child bearing potential must have a negative urine pregnancy test result upon entry into the study.
* Subjects must agree to abstain from sexual intercourse throughout the first 7 days of the study. Following the first 7 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.
* Subjects must be willing to abstain from alcohol ingestion during the 5 day treatment period and for 1 day afterward.
* Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).
Exclusion Criteria
* Subjects with a Gram's stain slide Nugent score \<4.
* Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization.
* Subjects who have taken disulfuram within 14 days or randomization.
* Subjects who have demonstrated a previous hypersensitivity reaction to metronidazole, either orally or topically administered, or any form or parabens.
* Subjects with primary or secondary immunodeficiency.
* Women who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
* Subjects who are pregnant, breast feeding, or planning a pregnancy.
* Subjects who are menstruating at the time of diagnosis.
* Subjects with intrauterine devices.
* Concurrent anticoagulation therapy with coumadin or warfarin.
* Concurrent use of systemic corticosteroids or systemic antibiotics.
* Subjects with clinically significant unstable medical disorders, life threatening diseases or current malignancies.
* Subjects previously enrolled in this study.
* Subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days.
* Subjects who are unwilling or unable to comply with the requirements of the protocol.
18 Years
FEMALE
No
Sponsors
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Teva Pharmaceuticals USA
INDUSTRY
Locations
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Clinic for Women, PA
Huntsville, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Edinger Medical Group
Fountain Valley, California, United States
Office of Drs. Shepard and Lugerner, PC
Washington D.C., District of Columbia, United States
Meadowcrest Women's Center
Crystal River, Florida, United States
Florida Medical and Research Institute, PA
Gainesville, Florida, United States
The Florida Wellcare Alliance, LC
Inverness, Florida, United States
Wellness Center for Gyn & Osteoporosis
Inverness, Florida, United States
Florida Medical and Research Institute, PA
Ocala, Florida, United States
KGR, LLC
Riverdale, Georgia, United States
Women's Health Practice
Champaign, Illinois, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, United States
Phoenix Ob-Gyn Associated
Moorestown, New Jersey, United States
Phoenix Ob-Gyn Associates
Mount Holly, New Jersey, United States
Kings County Hospital Center
Brooklyn, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Chapel Hill Obstetrics and Gynecology, PA
Chapel Hill, North Carolina, United States
Cooperfield Obstetrics and Gynecology, LLC
Concord, North Carolina, United States
O.U. Physicians' Building
Oklahoma City, Oklahoma, United States
The OU Medical Center
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Services Center
Oklahoma City, Oklahoma, United States
Medford Women's Clinic
Medford, Oregon, United States
Philadelphia Women's Research
Philadelphia, Pennsylvania, United States
Elite Medical Research, Inc.
Sellersville, Pennsylvania, United States
Stonebridge OB/GYN Associates
Sellersville, Pennsylvania, United States
Anderson Family Care
Anderson, South Carolina, United States
Carolina OB/GYN
Anderson, South Carolina, United States
Primary Care Associates
Anderson, South Carolina, United States
Radiant Research
Anderson, South Carolina, United States
Research Memphis
Memphis, Tennessee, United States
Millennium Clinical Research Center, LLC
Arlington, Virginia, United States
Women's Health Associates, PC
Fairfax, Virginia, United States
Office of H. Sharon Sethi
Fairfax, Virginia, United States
MedSource, Inc.
Richmond, Virginia, United States
Office of Max S. Maizels, MD
Richmond, Virginia, United States
Office of Prescott W. Prillaman, MD, PC
Richmond, Virginia, United States
Countries
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Other Identifiers
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TCR-03
Identifier Type: -
Identifier Source: org_study_id
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