drugset / Trial / NCT02515656
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Phase 3
Completed
661 enrolled
Laboratoire Innotech International
International Clinical Trials Association · collabVenn Life Sciences · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2015-09
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Miconazole | Small molecule | 400 mg | Other |
| Subject | Neomycin | Unknown | 35000 iu | Other |
| Subject | Nystatin | Unknown | 100000 iu | Other |
| Subject | Polymyxin B | Peptide | 35000 iu | Other |