At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 186 enrolled
Drug / intervention
Fluconazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
In Brief
A Phase 2 clinical trial evaluating Fluconazole and SCY-078 for Candida Vulvovaginitis. Completed, enrolled 186 participants across 25 sites.
Detailed Summary
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandida Vulvovaginitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedAug 2017
Primary CompletionMay 2018
TodayJul 2026
First PostedAug 17, 2017
Enrollment StartAug 1, 2017
Primary CompletionMay 4, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.9 years ago
Interventions
Fluconazoledrug
Oral Antifungal comparator
SCY-078drug
Investigational Antifungal