The Study Of Fluconazole For Vulvovaginal Candidiasis

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806623
• Other study ID #: A0561023
• Status: Completed
• Phase: Phase 3
• Start date: March 5, 2013
• Est. completion date: November 22, 2013

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: November 22, 2013
• Est. primary completion date: November 22, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Fluconazole
Single oral dose of 150mg Fluconazole

Locations

Country	Name	City	State
Japan	Ai WOMEN'S CLINIC	Asahikawa	Hokkaido
Japan	Mori Ladies Clinic	Fukuoka
Japan	IZUMI Ladies' Clinic	Gifu
Japan	Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine	Kagoshima
Japan	Shirokane Ladies' Clinic	Minato-ku	Tokyo
Japan	Women's Clinic Kamimura	Okayama
Japan	Hayakawa Clinic	Osaka
Japan	Sutou Ladies Clinic	Osaka
Japan	Takane Medical Clinic	Shinagawa-ku	Tokyo
Japan	Suzuran Clinic	Suginami-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maximum Observed Plasma Concentration (Cmax)		Before dosing and 2, 24, 48 and 168 hours after dosing
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Before dosing and 2, 24, 48 and 168 hours after dosing
Secondary	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
Secondary	Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight		Before dosing and 2, 24, 48 and 168 hours after dosing
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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