At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 376 enrolled
Drug / intervention
Ibrexafungerp +1 moredrug
Likely dose
Ibrexafungerp 300 mgfrom 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
In Brief
A Phase 3 clinical trial evaluating Ibrexafungerp and Placebo for Candida Vulvovaginitis. Completed, enrolled 376 participants across 25 sites.
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
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartJan 2019
Primary CompletionAug 2019
Study CompletionSep 2019
TodayJul 2026
First PostedNov 8, 2018
Enrollment StartJan 4, 2019
Primary CompletionAug 21, 2019
Study CompletionSep 4, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.6 years ago
Interventions
Ibrexafungerpdrug
Ibrexafungerp 300 mg BID for 1 day
Placebodrug
Matching placebo