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-VaginalŪ metronidazole vaginal gel, 0. 75% to establish clinical
equivalence in the treatment of bacterial vaginosis.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
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, 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
Office of H. Sharon Sethi, Fairfax, Virginia 22033, United States
Women's Health Associates, PC, Fairfax, Virginia 22031, 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