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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Metronidazole

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center, Inc.
    • Huntsville, Alabama, United States, 35801
      • Clinic for Women, PA
  • California
    • Fountain Valley, California, United States, 92708
      • Edinger Medical Group
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • Office of Drs. Shepard and Lugerner, PC
  • Florida
    • Crystal River, Florida, United States, 34429
      • Meadowcrest Women's Center
    • Gainesville, Florida, United States, 32607
      • Florida Medical and Research Institute, PA
    • Inverness, Florida, United States, 34452
      • The Florida Wellcare Alliance, LC
    • Inverness, Florida, United States, 34452
      • Wellness Center for Gyn & Osteoporosis
    • Ocala, Florida, United States, 34471
      • Florida Medical and Research Institute, PA
  • Georgia
    • Riverdale, Georgia, United States, 30274
      • KGR, LLC
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Inc.
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • New Orleans Institute of Clinical Investigation
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Phoenix Ob-Gyn Associated
    • Mount Holly, New Jersey, United States, 08060
      • Phoenix Ob-Gyn Associates
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Brooklyn, New York, United States, 11203
      • Kings County Hospital Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Chapel Hill Obstetrics and Gynecology, PA
    • Concord, North Carolina, United States, 28025
      • Cooperfield Obstetrics and Gynecology, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • O.U. Physicians' Building
    • Oklahoma City, Oklahoma, United States, 73104
      • The OU Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Services Center
  • Oregon
    • Medford, Oregon, United States, 97504
      • Medford Women's Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Philadelphia Women's Research
    • Sellersville, Pennsylvania, United States, 18960
      • Elite Medical Research, Inc.
    • Sellersville, Pennsylvania, United States, 18960
      • Stonebridge OB/GYN Associates
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research
    • Anderson, South Carolina, United States, 29621
      • Primary Care Associates
    • Anderson, South Carolina, United States, 29621
      • Anderson Family Care
    • Anderson, South Carolina, United States, 29621
      • Carolina OB/GYN
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Research Memphis
  • Virginia
    • Arlington, Virginia, United States, 22203
      • Millennium Clinical Research Center, LLC
    • Fairfax, Virginia, United States, 22031
      • Women's Health Associates, PC
    • Fairfax, Virginia, United States, 22033
      • Office of H. Sharon Sethi
    • Richmond, Virginia, United States, 23229
      • MedSource, Inc.
    • Richmond, Virginia, United States, 23229
      • Office of Max S. Maizels, MD
    • Richmond, Virginia, United States, 23229
      • Office of Prescott W. Prillaman, MD, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)	Drug: Metronidazole; Vaginal Gel, 0.75%; Other Names: MetroGel-Vaginal®
Active Comparator: 2; MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)	Drug: Metronidazole; Vaginal Gel, 0.75%; Other Names: MetroGel-Vaginal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Therapeutic cure rate at the Post-Treatment Visit	Visit 2

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimated): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Metronidazole; Bioequivalence; Vaginosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: TCR-03