Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis

Completed · Phase 1/Phase 2

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT01020396

Run by

Teva Pharmaceuticals USA

People needed

579

Starts

2002-01-01

Expected to finish

2003-03-01

Last updated by the study team

2024-08-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.
• Subjects who are unwilling or unable to comply with the requirements of the protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

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