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

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis

Intervention: Metronidazole (Drug); Metronidazole (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Teva Pharmaceuticals USA


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.

Clinical Details

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-VaginalŪ Metronidazole Vaginal Gel, 0.75% in the Treatment of Bacterial Vaginosis

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Primary outcome:

Therapeutic cure rate of the subject at the Test-of-Cure Visit.

Incidence of Adverse Effects reported throughout the study.

Secondary outcome: Therapeutic cure rate at the Post-Treatment Visit


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.

Locations and Contacts

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

Additional Information

Starting date: January 2002
Last updated: November 24, 2009

Page last updated: August 23, 2015

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