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Safety and Tolerability of Metronidazole Gel 1.3%

NCT02392026 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-15

No results posted yet for this study

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.

Conditions

  • Vaginosis, Bacterial

Interventions

DRUG

Metronidazole Gel

Metronidazole Vaginal Gel 1.3% administered via applicator

Sponsors & Collaborators

  • Allergan Sales, LLC

    collaborator INDUSTRY

  • Insud Pharma

    lead INDUSTRY

Principal Investigators

  • Gina Giannantoni-Ibelli, MS · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-12
Primary Completion
2016-10-05
Completion
2016-10-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392026 on ClinicalTrials.gov