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Clinical Trial Summary

This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.


Clinical Trial Description

This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03253094
Study type Interventional
Source Scynexis, Inc.
Contact
Status Completed
Phase Phase 2
Start date August 1, 2017
Completion date May 4, 2018

See also
  Status Clinical Trial Phase
Completed NCT03987620 - Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis Phase 3
Completed NCT03734991 - Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303) Phase 3
Recruiting NCT04219605 - Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions