CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Ibrexafungerpdrug
Likely dose
Ibrexafungerp 300 mg daily (150 mg orally twice daily)AI-extracted
Key inclusion· 11
  • ✓Post-menarchal female age ≥18 years
  • ✓Symptomatic VVC with composite vulvovaginal signs and symptoms score ≥4, with at least 2 signs/symptoms scoring ≥2 (moderate)
  • ✓Positive microscopic examination with 10% KOH showing yeast forms (hyphae/pseudohyphae) or budding yeasts
  • ✓Normal vaginal pH ≤4.5
Key exclusion· 8
  • ✕Concurrent vaginal conditions other than VVC (bacterial vaginosis, Trichomonas, herpes, gonorrhea, chlamydia, symptomatic HPV, or mixed infections)
  • ✕Systemic or topical vaginal antifungal treatment within 7 days prior to screening
  • ✕Active menstruation at the screening visit
  • ✕History of or active cervical/vaginal cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05399641
NCT05399641Phase 3Completed
CompareCT.gov

Oral Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (VVC) in Subjects Who Have Failed Fluconazole Therapy

Scynexis, Inc.·interventional·Posted Jun 1, 2022·Updated Jul 10, 2024

In Brief

A Phase 3 clinical trial evaluating Ibrexafungerp for Vulvovaginal Candidiasis. Completed, enrolled 150 participants across 25 sites.

Detailed Summary

This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJun 1, 2022
Enrollment StartMay 1, 2022
Primary CompletionMay 16, 2023
Study CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.1 years ago

Interventions

Ibrexafungerpdrug

Each day dosing will consist of two 150mg tablets taken BID.