Status:
COMPLETED
The Study Of Fluconazole For Vulvovaginal Candidiasis
Lead Sponsor:
Pfizer
Conditions:
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
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 an...
Eligibility Criteria
Inclusion
- 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
- Patients with a history of hypersensitivity to fluconazole.
- Patients with severe renal dysfunction.
- Patients with liver disorder.
Key Trial Info
Start Date :
March 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2013
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01806623
Start Date
March 5 2013
End Date
November 22 2013
Last Update
July 19 2021
Active Locations (10)
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1
Ai WOMEN'S CLINIC
Asahikawa, Hokkaido, Japan, 070-8003
2
Shirokane Ladies' Clinic
Minato-ku, Tokyo, Japan, 108-0071
3
Takane Medical Clinic
Shinagawa-ku, Tokyo, Japan, 140-0013
4
Suzuran Clinic
Suginami-ku, Tokyo, Japan, 167-0051