Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
Following completion of the Phase 2, multicenter, randomized, active-controlled study of the safety and tolerability of two formulations of CD101 compared to fluconazole for the treatment of moderate to severe episodes of acute vulvovaginal candidiasis (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.
Study Type
OBSERVATIONAL
Enrollment
32
Precision Trials AZ
Phoenix, Arizona, United States
Time to recurrence of clinical signs/symptoms of VVC
Time to recurrence of clinical signs/symptoms of VVC
Time frame: Up to Day 90 +/- 14 days
Rate of candida colonization
Rate of candida colonization
Time frame: Up to Day 90 +/- 14 days
Rate of recurrence of clinical signs/symptoms of VVC
Rate of recurrence of clinical signs/symptoms of VVC
Time frame: Up to Day 90 +/- 14 days
Time to recurrence of culture confirmed VVC
Time to recurrence of culture confirmed VVC
Time frame: Up to Day 90 +/- 14 days
Rates of recurrence of culture confirmed VVC
Rates of recurrence of culture confirmed VVC
Time frame: Up to Day 90 +/- 14 days
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