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The Study Of Fluconazole For Vulvovaginal Candidiasis

NCT01806623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2021-07-19

Study results available
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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.

Conditions

  • Vulvovaginal Candidiasis

Interventions

DRUG

Fluconazole

Single oral dose of 150mg Fluconazole

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-05
Primary Completion
2013-11-22
Completion
2013-11-22

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01806623 on ClinicalTrials.gov