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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
CD101 external gel (1%) applied topically twice daily over 72 hours as needed
CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
adverse events, clinical chemistry and hematology, pelvic exams
Time frame: Day 28 - 35
Change in Vulvovaginal Scoring System
Change in clinical signs and subject symptoms of VVC
Time frame: Day 7 (+/- 2days)
Change in Vulvovaginal Scoring System
Change in clinical signs and subject symptoms of VVC
Time frame: Day 14 (+/- 2days)
Change in Vulvovaginal Scoring System
Change in clinical signs and subject symptoms of VVC
Time frame: Day 28 - 35
Mycological Culture
Culture negative for Candida
Time frame: Day 7 (+/- 2days)
Mycological Culture
Culture negative Candida
Time frame: Day 14 (+/- 2days)
Mycological Culture
Culture negative Candida
Time frame: Day 28 -35
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CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
oral fluconazole (150mg) on Day 1
Precision Trials AZ LLC
Phoenix, Arizona, United States
The Women's Clinical, P.A.
Little Rock, Arkansas, United States
Women's Health Care Research Corp
San Diego, California, United States
Olympian Clinical Research
Clearwater, Florida, United States
Women's Medical Research
Clearwater, Florida, United States
Altus Research Inc
Lake Worth, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
Augusta University
Augusta, Georgia, United States
Clinical Trials Management LLC
Metairie, Louisiana, United States
...and 14 more locations