Methods
215 patients with clinical and mycologic diagnosis of RVVC (3 or more acute episodes within the previous 12 month) were enrolled. At screening, patients were required to have a vulvovaginal signs and symptoms (S&S) score of ≥3 and a positive KOH. After an induction phase of 3 doses of 150 mg fluconazole every 3 days to treat the acute episode, patients with a S&S score of <3 were randomized for maintenance therapy to: 1) 150 mg once-daily for 7 days, then 150 mg once-weekly for 11 weeks, then matching placebo for 12 weeks; 2) 300 mg once-daily for 7 days, then 300 mg once-weekly for 11 weeks, then matching placebo for 12 weeks; 3) 150 mg once-daily for 7 days, then 150 mg once-weekly for 23 weeks; 4) 300 mg once-daily for 7 days, then 300 mg once-weekly for 23 weeks or 5) matching placebo regimen for 24 weeks.
Methods
215 patients with clinical and mycologic diagnosis of RVVC (3 or more acute episodes within the previous 12 month) were enrolled. At screening, patients were required to have a vulvovaginal signs and symptoms (S&S) score of ≥3 and a positive KOH. After an induction phase of 3 doses of 150 mg fluconazole every 3 days to treat the acute episode, patients with a S&S score of <3 were randomized for maintenance therapy to: 1) 150 mg once-daily for 7 days, then 150 mg once-weekly for 11 weeks, then matching placebo for 12 weeks; 2) 300 mg once-daily for 7 days, then 300 mg once-weekly for 11 weeks, then matching placebo for 12 weeks; 3) 150 mg once-daily for 7 days, then 150 mg once-weekly for 23 weeks; 4) 300 mg once-daily for 7 days, then 300 mg once-weekly for 23 weeks or 5) matching placebo regimen for 24 weeks.
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