NCT01806623

The Study Of Fluconazole For Vulvovaginal Candidiasis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Fluconazole	Single oral dose of 150mg Fluconazole

Timeline

• Start date: 2013-03-05
• Primary completion: 2013-11-22
• Completion: 2013-11-22
• First posted: 2013-03-07
• Last updated: 2021-07-19
• Results posted: 2014-12-03

Locations

10 sites across 1 country: Japan