NCT01806623

The Study Of Fluconazole For Vulvovaginal Candidiasis

Completed Phase 3 Results posted Last updated 19 July 2021

What this trial tests

Phase 3 trial testing Fluconazole in Vulvovaginal Candidiasis in 157 participants. Completed in 22 November 2013.

Timeline

5 March 2013

Primary endpoint
22 November 2013

22 November 2013

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	157
Start date	5 March 2013
Primary completion	22 November 2013
Estimated completion	22 November 2013
Sites	10 locations across Japan

Drugs / interventions tested

• Fluconazole (fluconazole) — full drug profile →

Conditions studied

• Vulvovaginal Candidiasis — all drugs for Vulvovaginal Candidiasis →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 80, female only, with Vulvovaginal Candidiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan.
   Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, et al · · 2015 · cited 4× · PMID 25887336 · DOI 10.1016/j.jiac.2015.03.011