Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis

This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.

 

Condition Intervention Phase
Vulvovaginal Candidiasis Drug: SCY-078
Drug: Fluconazole
Phase 2

 

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis

Antifungal name: 

Date of article/Start date of trial: 

Tuesday, January 19, 2016

Trial phase: 

Phase 2

ClinicalTrials.gov ID: 

NCT02679456

Trial status: 

Active
New antifungal drugs