The Study Of Fluconazole For Vulvovaginal Candidiasis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806623

A0561023

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Patients with a history of hypersensitivity to fluconazole.
• Patients with severe renal dysfunction.
• Patients with liver disorder.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 1 patient group

Fluconazole

Experimental group

Treatment:

Drug: Fluconazole