Safety and Tolerability of Metronidazole Gel 1.3%

August 10, 2023 updated by: Insud Pharma

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Metronidazole Vaginal Gel 1.3% in Adolescent Female Subjects With Bacterial Vaginosis

Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to <18 years for 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.

Detailed Description

A multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel 1.3% when administered as a single dose in adolescent females (aged 12 to <18 years) for the treatment of bacterial vaginosis.

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.
60

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 4

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
    • California
      • Long Beach, California, United States, 90806
        • Allergan Research Site #318
      • Paramount, California, United States, 90723
        • Allergan Research Site #324
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Allergan Research Site #315
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Allergan Research Site #314
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Allergan Research Site #319
      • Dayton, Ohio, United States, 45406
        • Allergan Research Site #322
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Allergan Research Site #321
    • Texas
      • Irving, Texas, United States, 75062
        • Allergan Research Site #316

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provide written assent and parent/legal guardian informed consent and authorization to disclose protected health information.
  • Post-menarcheal, adolescent female, 12 to <18 years of age at time of Screening/Baseline Visit (Day 1).
  • In good general health at Screening visit with no known medical conditions that, in the Investigator's opinion, may interfere with study participation.
  • Has negative urine pregnancy test result prior to study treatment initiation.
  • Has clinical diagnosis of bacterial vaginosis.
  • Agree to abstain from sexual intravaginal intercourse for study duration.
  • Willing to avoid alcohol ingestion for 24 hours after administration of test article.
  • Agree to refrain from use of intravaginal products for duration of study (e.g. lubricated condoms, tampons, diaphragms, spermicides, feminine deodorant sprays, douches). Intravaginal Uterine Device (IUD) use is acceptable as long as it has been in place for 30 days prior to study enrollment.
  • Willing and able to participate in study, make required visits to the study center, and comply with all study requirements including concomitant medication and other treatment restrictions.

Exclusion Criteria:

  • Pregnant, lactating, or planning to become pregnant during study period.
  • Currently menstruating or anticipate onset of menses during first 9 days of the study.
  • Experience a clinically important medical event with 90 days of Screening/Baseline Visit (Day 1).
  • Evidence of other infectious causes of vulvovaginal infection or condition that in the Investigator's opinion would confound the interpretation of the study results.
  • Severe symptoms of dysuria and/or pruritus, burning or irritation in vulvovaginal area.
  • Received systemic or intravaginal antifungal, antibacterial or antiparasitic drugs within 14 days of Screening/Baseline visit (Day 1). Antiviral therapies (non-intravaginal) are acceptable.
  • Has taken disulfiram or systemic corticosteroids (oral or injected) within 14 days of Screening/Baseline Visit (Day 1).
  • Had sexual intravaginal intercourse within 24 hours of Screening/Baseline (Day 1).
  • Demonstrated previous hypersensitivity to metronidazole, either orally or topically administered, or any form of parabens or benzyl alcohol.
  • Known primary or secondary immunodeficiency condition/syndrome.
  • Being treated or planning to be treated during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
  • Using anticoagulation therapy with Coumadin (warfarin).
  • Previously treated with test article under this protocol.
  • Participate in an experimental drug/device trial within the last 30 days before Screening/Baseline Visit (Day 1).
  • Is judged by the Investigator to be unsuitable for any reason.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Metronidazole Gel
Metronidazole Vaginal Gel
Drug: Metronidazole Gel
Metronidazole Vaginal Gel 1.3% administered via applicator
Other Names:
  • Metro Gel

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
Measure Description
Time Frame
Number of subjects with treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs and AEs leading to study discontinuation after Metronidazole Vaginal Gel is administered in post-menarcheal, adolescent females with bacterial vaginosis.
Time Frame: up to 10 days
No serious AEs reported during the completed study
up to 10 days
A multicenter open label to evaluate safety and tolerability of metronidazole vaginal gel 1.3% for adolescents female subject with bacterial and vaginosis
Time Frame: up tp 10 days
Metronidazole Vaginal Gel 1.3% is safe, well tolerated, and efficacious in treating vaginal discharge and odor in adolescent females aged 12 to < 18 years with bacterial vaginosis. The safety and efficacy profiles in this study were consistent with the known safety and efficacy profiles for the adult population and no new safety concerns were identified.
up tp 10 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
Measure Description
Time Frame
Number of subjects reporting presence of daily vaginal discharge and/or odor following single dose administration of Metronidazole Vaginal Gel 1.3%assessment of the presence of vaginal discharge and odor following single dose administration.
Time Frame: up to 10 days
no order or smelling observed
up to 10 days

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.
Insud Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Allergan Sales, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gina Giannantoni-Ibelli, MS, Allergan

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 (Actual)

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.
August 12, 2015

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.
October 5, 2016

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.
October 5, 2016

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).
March 4, 2015

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.
March 12, 2015

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.
March 18, 2015

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 15, 2023

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 10, 2023

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, 2023

More Information

Terms related to this study

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.
  • MG1401

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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