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Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

NCT01055106 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2011-07-01

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.

Conditions

  • Vaginosis, Bacterial
  • Vaginal Infection

Interventions

DRUG

GW05

vaginal gel once daily regimen A

DRUG

GW05

vaginal gel once daily regimen B

DRUG

GW05

vaginal gel once daily regimen C

DRUG

Metronidazole

vaginal gel 0.75% once daily for 5 days

Sponsors & Collaborators

  • Graceway Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Sharon F Levy, MD · Graceway Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

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 NCT01055106 on ClinicalTrials.gov