NCT02733432

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

A Phase 2, 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), \& Day 28 (+/-7 days) to assess therapeutic cure and safety.

Conditions

• Candidiasis, Vulvovaginal
• Mycoses
• Yeast Infection
• Moniliasis, Vulvovaginal
• Vaginitis, Monilial

Interventions

Type	Name	Description
DRUG	CD101 Vaginal Gel (3%)	CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
DRUG	CD101 External gel (1%)	CD101 external gel (1%) applied topically twice daily over 72 hours as needed
DRUG	CD101 Vaginal Ointment (6%)	CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
DRUG	CD101 External ointment (1%)	CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
DRUG	Fluconazole	oral fluconazole (150mg) on Day 1

Timeline

• Start date: 2016-06-08
• Primary completion: 2016-11-23
• Completion: 2016-12-23
• First posted: 2016-04-11
• Last updated: 2020-08-31

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study