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Safety and Tolerability of Metronidazole Gel 1.3%

Sponsor
Insud Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02392026
Collaborator
Allergan Sales, LLC (Industry)
60
Enrollment
8
Locations
1
Arm
15.7
Actual Duration (Months)
7.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Metronidazole Gel
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Metronidazole Vaginal Gel 1.3% in Adolescent Female Subjects With Bacterial Vaginosis
Actual Study Start Date :
Aug 11, 2015
Actual Primary Completion Date :
Oct 31, 2016
Actual Study Completion Date :
Nov 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metronidazole Gel

Metronidazole Vaginal Gel

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [up to 10 days]

    Secondary Outcome Measures

    1. 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. [up to 10 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allergan Research Site #318 Long Beach California United States 90806
    2 Allergan Research Site #324 Paramount California United States 90723
    3 Allergan Research Site #315 Bardstown Kentucky United States 40004
    4 Allergan Research Site #314 New Orleans Louisiana United States 70115
    5 Allergan Research Site #319 Columbus Ohio United States 43231
    6 Allergan Research Site #322 Dayton Ohio United States 45406
    7 Allergan Research Site #321 Memphis Tennessee United States 38104
    8 Allergan Research Site #316 Irving Texas United States 75062

    Sponsors and Collaborators

    • Insud Pharma
    • Allergan Sales, LLC

    Investigators

    • Study Director: Gina Giannantoni-Ibelli, MS, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Insud Pharma
    ClinicalTrials.gov Identifier:
    NCT02392026
    Other Study ID Numbers:
    • MG1401
    First Posted:
    Mar 18, 2015
    Last Update Posted:
    Oct 24, 2019
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Vaginosis, Bacterial
    Vaginal Diseases
    Metronidazole

    Study Results

    No Results Posted as of Oct 24, 2019