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Safety and Efficacy Study to Treat Bacterial Vaginosis

NCT01621399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 651

Last updated 2013-08-21

No results posted yet for this study

Summary

The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

Product 55394

Product 55394 vaginal gel in a prefilled applicator.

DRUG

Placebo Vehicle (non-treatment)

The vehicle vaginal gel in an applicator (placebo).

Sponsors & Collaborators

  • Medicis Global Service Corporation

    lead INDUSTRY

Principal Investigators

  • Ron Staugaard · Medicis Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-10-31
Completion
2012-12-31

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 NCT01621399 on ClinicalTrials.gov