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Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule — One-Shot  

Bacterial Vaginosis Clinical Trial

Official title:
Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fenticonazole + Tinidazole + Lidocaine in the Treatment of Bacterial Vaginosis, Candidal Vulvovaginitis, Trichomonal Vaginitis and Mixed Infections

Clinical Trial Summary

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

Clinical Trial Description

This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye. It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and mixed infections with comparison to Gynomax® XL vaginal ovule. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06056947
Study type Interventional
Source Ege University
Contact
Status Completed
Phase Phase 3
Start date July 20, 2020
Completion date August 26, 2021
View Details
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