The Study Of Fluconazole For Vulvovaginal Candidiasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-05

Study Completion Date

2013-11-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Vulvovaginal Candidiasis

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluconazole

Group Type EXPERIMENTAL

Fluconazole

Intervention Type DRUG

Single oral dose of 150mg Fluconazole

Interventions

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Fluconazole

Single oral dose of 150mg Fluconazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with clinical symptoms and signs of vulvovaginal candidiasis.
* Patients tested positive for Candida by fungal culture.
* Patients who can agree not to have intercourse up to 28 days after dosing.