CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
Fluconazole Tablet +2 moredrug
Likely dose
Fluconazole Tablet 150 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.

Search/NCT04029116
NCT04029116Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

Scynexis, Inc.·interventional·Posted Jul 23, 2019·Updated Jun 18, 2023

In Brief

A Phase 3 clinical trial evaluating Fluconazole Tablet, IBREXAFUNGERP, and 1 other intervention for Recurrent Vulvovaginal Candidiasis. Completed, enrolled 440 participants across 25 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Vulvovaginal Candidiasis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartOct 21, 2019
Primary CompletionSep 1, 2021
Study CompletionNov 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.9 years ago

Interventions

Fluconazole Tabletdrug

150 mg every 72 hours for 3 doses

IBREXAFUNGERPdrug

300 mg BID (one day) every 4 weeks for a total of 6 dosing days

Placebo oral tabletdrug

BID (one day) every 4 weeks for a total of 6 dosing days