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

August 16, 2024 updated by: Teva Pharmaceuticals USA

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
579

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Therapeutic cure rate of the subject at the Test-of-Cure Visit.
Time Frame: Visit 3
Visit 3
Incidence of Adverse Effects reported throughout the study.
Time Frame: 29 Days
29 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Therapeutic cure rate at the Post-Treatment Visit
Time Frame: Visit 2
Visit 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCR-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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