drugset / Trial / NCT01806623

The Study Of Fluconazole For Vulvovaginal Candidiasis

NCT01806623

Phase 3 Completed 157 enrolled Pfizer
NaParallel-groupOpen-labelTreatment

Summary

As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.

Timeline

Start
2013-03-05
Primary completion
2013-11-22
Completion
2013-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluconazole Small molecule 150 mg Oral