Clinical trial NCT01806623: The Study Of Fluconazole For Vulvovaginal Candidiasis
Official title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Candidiasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Outcome: Response Rate
timeFrame: Day 7, Day 14 and Day 28
Secondary outcomes:
measure: Clinical Efficacy: Cure Rate
timeFrame: Day 7, Day 14 and Day 28
measure: Clinical Efficacy: Cure and Improvement Rate
timeFrame: Day 7, Day 14 and Day 28
measure: Mycological Efficacy: Eradication Rate
timeFrame: Day 7, Day 14 and Day 28
measure: Total Scores for Clinical Symptoms
timeFrame: Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
timeFrame: Before dosing and 2, 24, 48 and 168 hours after dosing
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Ai WOMEN'S CLINIC
state: Hokkaido
city: Minato-ku
country: Japan
facility: Shirokane Ladies' Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Takane Medical Clinic
state: Tokyo
city: Suginami-ku
country: Japan
facility: Suzuran Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Mori Ladies Clinic
city: Gifu
country: Japan
facility: IZUMI Ladies' Clinic
city: Kagoshima
country: Japan
facility: Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine
city: Okayama
country: Japan
facility: Women's Clinic Kamimura
city: Osaka
country: Japan
facility: Sutou Ladies Clinic
city: Osaka
country: Japan
facility: Hayakawa Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, Nagashima M. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan. J Infect Chemother. 2015 Jul;21(7):520-6. doi: 10.1016/j.jiac.2015.03.011. Epub 2015 Mar 30.