Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
Status:
Completed
Trial end date:
2016-08-05
Target enrollment:
Participant gender:
Summary
This is a randomized, multicenter, evaluator blinded study to evaluate the safety,
tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult
patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent
episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled
and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose
regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of
treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation
period visit) or at any time that a recurrence or clinical failure is suspected, up to the
end of observation period.