Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
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
1 other identifier
interventional
579
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2002
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedAugust 19, 2024
August 1, 2024
1.2 years
November 24, 2009
August 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Therapeutic cure rate of the subject at the Test-of-Cure Visit.
Visit 3
Incidence of Adverse Effects reported throughout the study.
29 Days
Secondary Outcomes (1)
Therapeutic cure rate at the Post-Treatment Visit
Visit 2
Study Arms (2)
1
EXPERIMENTALMetronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)
2
ACTIVE COMPARATORMetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)
Interventions
Eligibility Criteria
You may qualify if:
- 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 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).
You may not qualify if:
- Subjects with known or suspected other infectious causes of vulvovaginitis (e.g. candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator's opinion, would confound the interpretation of the clinical response).
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Clinic for Women, PA
Huntsville, Alabama, 35801, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Edinger Medical Group
Fountain Valley, California, 92708, United States
Office of Drs. Shepard and Lugerner, PC
Washington D.C., District of Columbia, 20006, United States
Meadowcrest Women's Center
Crystal River, Florida, 34429, United States
Florida Medical and Research Institute, PA
Gainesville, Florida, 32607, United States
The Florida Wellcare Alliance, LC
Inverness, Florida, 34452, United States
Wellness Center for Gyn & Osteoporosis
Inverness, Florida, 34452, United States
Florida Medical and Research Institute, PA
Ocala, Florida, 34471, United States
KGR, LLC
Riverdale, Georgia, 30274, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, 70112, United States
Phoenix Ob-Gyn Associated
Moorestown, New Jersey, 08057, United States
Phoenix Ob-Gyn Associates
Mount Holly, New Jersey, 08060, United States
Kings County Hospital Center
Brooklyn, New York, 11203, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Chapel Hill Obstetrics and Gynecology, PA
Chapel Hill, North Carolina, 27514, United States
Cooperfield Obstetrics and Gynecology, LLC
Concord, North Carolina, 28025, United States
O.U. Physicians' Building
Oklahoma City, Oklahoma, 73104, United States
The OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Services Center
Oklahoma City, Oklahoma, 73104, United States
Medford Women's Clinic
Medford, Oregon, 97504, United States
Philadelphia Women's Research
Philadelphia, Pennsylvania, 19114, United States
Elite Medical Research, Inc.
Sellersville, Pennsylvania, 18960, United States
Stonebridge OB/GYN Associates
Sellersville, Pennsylvania, 18960, United States
Anderson Family Care
Anderson, South Carolina, 29621, United States
Carolina OB/GYN
Anderson, South Carolina, 29621, United States
Primary Care Associates
Anderson, South Carolina, 29621, United States
Radiant Research
Anderson, South Carolina, 29621, United States
Research Memphis
Memphis, Tennessee, 38116, United States
Millennium Clinical Research Center, LLC
Arlington, Virginia, 22203, United States
Women's Health Associates, PC
Fairfax, Virginia, 22031, United States
Office of H. Sharon Sethi
Fairfax, Virginia, 22033, United States
MedSource, Inc.
Richmond, Virginia, 23229, United States
Office of Max S. Maizels, MD
Richmond, Virginia, 23229, United States
Office of Prescott W. Prillaman, MD, PC
Richmond, Virginia, 23229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
January 1, 2002
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
August 19, 2024
Record last verified: 2024-08