title: Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan.
abstract: Vulvovaginal candidiasis is the second most common cause of vaginal infections following bacterial vaginosis. For the treatment of vulvovaginal candidiasis, antifungal agents are used either as topical (vaginal tablets and cream) or oral formulations. A single oral 150 mg dose of fluconazole has been recommended as the standard therapy for uncomplicated, acute vulvovaginal candidiasis in global guidelines; however, in Japan oral fluconazole therapy has not been approved. We conducted a phase 3 study to evaluate the efficacy and safety of a single oral 150 mg dose of fluconazole in Japanese subjects with vulvovaginal candidiasis for regulatory submission. A total of 157 subjects received a single oral 150 mg dose of fluconazole. Candida species (104 strains) were identified by fungal culture from 102 subjects at baseline, including Candida albicans (100 strains). The efficacy rate for the therapeutic outcome (assessed based on a comprehensive evaluation of the clinical and mycological efficacy in each subject) was 74.7% (74/99) on Day 28 in the modified Intent-To-Treat (m-ITT) population. Concerning the clinical and mycological efficacy on Day 28 in the m-ITT population, the cure, cure or improvement, and eradication rates were 81.6%, 95.9%, and 85.9%, respectively. The most common treatment-related adverse events were diarrhea and nausea (1.9% for each). No clinically significant safety issues were reported. A single oral 150 mg dose of fluconazole demonstrated excellent therapeutic efficacy and was well tolerated in Japanese subjects with vulvovaginal candidiasis.
  
  
  BACKGROUND
  NCT01806623.
authors.affiliation: Department of Clinical Infectious Diseases, Aichi Medical University Graduate School of Medicine, Aichi, Japan.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Mikamo
authors.affiliation: Clinical Research, Development Japan, Pfizer Japan Inc., Tokyo, Japan. Electronic address: miyako.matsumizu@pfizer.com.
authors.forename: Miyako
authors.initials: M
authors.lastname: Matsumizu
authors.affiliation: Clinical Statistics, Development Japan, Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Yoshiomi
authors.initials: Y
authors.lastname: Nakazuru
authors.affiliation: Clinical Statistics, Development Japan, Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Akifumi
authors.initials: A
authors.lastname: Okayama
authors.affiliation: Department of Clinical Infectious Diseases, Aichi Medical University Graduate School of Medicine, Aichi, Japan; Clinical Research, Development Japan, Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Masahito
authors.initials: M
authors.lastname: Nagashima
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D015725:Fluconazole
keywords: Candidal vulvovaginitis; Fluconazole; Single oral dose; Vulvovaginal candidiasis