Trials / Completed
CompletedNCT02515656
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 661 (actual)
- Sponsor
- Laboratoire Innotech International · Industry
- Sex
- Female
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | POLYGYNAX® | |
| DRUG | GYNODAKTARIN® | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2015-08-05
- Last updated
- 2019-01-22
- Results posted
- 2019-01-22
Locations
4 sites across 4 countries: Czechia, France, Serbia, Slovakia
Source: ClinicalTrials.gov record NCT02515656. Inclusion in this directory is not an endorsement.