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drugset / Trial / NCT04029116

Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

NCT04029116 ↗

Phase 3 Completed 440 enrolled Scynexis, Inc.
RandomizedParallel-groupTriple-blindPrevention

Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Timeline

Start
2019-10-21
Primary completion
2021-09-01
Completion
2021-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrexafungerp Small molecule 300 mg Oral
Background Fluconazole Small molecule 150 mg Oral

Indications

vulvovaginal candidiasis