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Safety and Tolerability of Metronidazole Gel 1.3%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02392026
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : October 23, 2017
Information provided by (Responsible Party):
Allergan ( Allergan Sales, LLC )

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
Vaginosis, Bacterial 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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 : August 11, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: Metronidazole Gel
Metronidazole Vaginal Gel
Drug: Metronidazole Gel
Metronidazole Vaginal Gel 1.3% administered via applicator
Other Name: Metro Gel

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. [ Time Frame: 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. [ Time Frame: up to 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02392026

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United States, California
Allergan Research Site #318
Long Beach, California, United States, 90806
Allergan Research Site #324
Paramount, California, United States, 90723
United States, Kentucky
Allergan Research Site #315
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Allergan Research Site #314
New Orleans, Louisiana, United States, 70115
United States, Ohio
Allergan Research Site #319
Columbus, Ohio, United States, 43231
Allergan Research Site #322
Dayton, Ohio, United States, 45406
United States, Tennessee
Allergan Research Site #321
Memphis, Tennessee, United States, 38104
United States, Texas
Allergan Research Site #316
Irving, Texas, United States, 75062
Sponsors and Collaborators
Allergan Sales, LLC
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Study Director: Gina Giannantoni-Ibelli, MS Allergan

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Responsible Party: Allergan Sales, LLC Identifier: NCT02392026     History of Changes
Other Study ID Numbers: MG1401
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents