CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 157 enrolled
Drug / intervention
Fluconazoledrug
Likely dose
Fluconazole 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01806623
NCT01806623Phase 3Completed
CompareCT.gov

A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.

Pfizer·interventional·Posted Mar 7, 2013·Updated Jul 19, 2021

In Brief

A Phase 3 clinical trial evaluating Fluconazole for Vulvovaginal Candidiasis. Completed, enrolled 157 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2013
Enrollment StartMar 5, 2013
Primary CompletionNov 22, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.3 years ago

Interventions

Fluconazoledrug

Single oral dose of 150mg Fluconazole