RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections

The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.

 

Condition Intervention Phase
Candidiasis, Vulvovaginal
Mycoses
Yeast Infection
Moniliasis, Vulvovaginal
Vaginitis, Monilial
Drug: CD101 gel (3%)
Drug: CD101 gel (1%)
Drug: CD101 ointment (6%)
Drug: CD101 ointment (1%)
Drug: Fluconazole
Phase 2

 

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

Antifungal name: 

Date of article/Start date of trial: 

Monday, March 28, 2016

Trial phase: 

Phase 2

ClinicalTrials.gov ID: 

NCT02733432

Trial status: 

Active
New antifungal drugs