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Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

NCT02515656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2019-01-22

Study results available
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Summary

POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.

The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.

Conditions

  • Vaginitis

Interventions

DRUG

POLYGYNAX®

DRUG

GYNODAKTARIN®

DRUG

Placebo

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Venn Life Sciences

    collaborator OTHER

  • Laboratoire Innotech International

    lead INDUSTRY

Principal Investigators

  • Jean-Marc BOHBOT, Dr · Institut Alfred Fournier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Czechia
  • France
  • Serbia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

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 NCT02515656 on ClinicalTrials.gov