The Study Of Fluconazole For Vulvovaginal Candidiasis

Study Overview
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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.

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

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Fluconazole


Participation Criteria
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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. Exclusion Criteria: Patients with a history of hypersensitivity to fluconazole. Patients with severe renal dysfunction. Patients with liver disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluconazole<br> | Drug: Fluconazole<br>* Single oral dose of 150mg Fluconazole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7, Day 14 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28 | 
| Maximum Observed Plasma Concentration (Cmax) |  | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight |  | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight |  | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight | Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid |  | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid |  | Before dosing and 2, 24, 48 and 168 hours after dosing | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid | Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid | Before dosing and 2, 24, 48 and 168 hours after dosing |