At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole
In Brief
A Phase 3 clinical trial evaluating POLYGYNAX®, GYNODAKTARIN®, and 1 other intervention for Vaginitis. Completed, enrolled 661 participants across 4 sites in 4 countries.
Detailed 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.