At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 455 enrolled
Drug / intervention
Ibrexafungerp +1 moredrug
Likely dose
Ibrexafungerp 300mgfrom 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 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (AVVC).
In Brief
A Phase 3 clinical trial evaluating Ibrexafungerp and Placebo for Candida Vulvovaginitis. Completed, enrolled 455 participants across 41 sites in 2 countries.
Detailed Summary
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandida Vulvovaginitis
CountriesBulgaria, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJun 2019
First PostedJun 2019
Primary CompletionMar 2020
Study CompletionApr 2020
TodayJul 2026
First PostedJun 17, 2019
Enrollment StartJun 7, 2019
Primary CompletionMar 29, 2020
Study CompletionApr 29, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.0 years ago
Interventions
Ibrexafungerpdrug
Ibrexafungerp 300mg BID for one day
Placebodrug
Matching Placebo