The Study Of Fluconazole For Vulvovaginal Candidiasis

Pfizer157 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Vulvovaginal Candidiasis

Interventions

FluconazoleDRUG

Single oral dose of 150mg Fluconazole

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (10)

Ai WOMEN'S CLINIC

Asahikawa, Hokkaido, Japan

Shirokane Ladies' Clinic

Minato-ku, Tokyo, Japan

Takane Medical Clinic

Shinagawa-ku, Tokyo, Japan

Suzuran Clinic

Suginami-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Therapeutic Outcome: Response Rate

Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication. Primary evaluation of therapeutic outcome was on Day 28. Response rate was calculated based on the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

Time frame: Day 7, Day 14 and Day 28

Secondary Outcomes

Clinical Efficacy: Cure Rate

Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined). Cure rate was calculated based on the following formula, "the number of participants assessed as Cure" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.

Time frame: Day 7, Day 14 and Day 28

Clinical Efficacy: Cure and Improvement Rate

Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined). Cure and improvement rate was calculated based on the following formula, "the number of participants assessed as Cure or Improvement" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.

Data from ClinicalTrials.gov

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Mori Ladies Clinic

Fukuoka, Japan

IZUMI Ladies' Clinic

Gifu, Japan

Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine

Kagoshima, Japan

Women's Clinic Kamimura

Okayama, Japan

Sutou Ladies Clinic

Osaka, Japan

Hayakawa Clinic

Osaka, Japan

Time frame: Day 7, Day 14 and Day 28

Mycological Efficacy: Eradication Rate

Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate. Eradication rate was calculated based on the following formula, "the number of participants assessed as Eradication" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.

Time frame: Day 7, Day 14 and Day 28

Total Scores for Clinical Symptoms

Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).

Time frame: Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28

Maximum Observed Plasma Concentration (Cmax)