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
1 other identifier
interventional
126
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2016
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedStudy Start
First participant enrolled
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2016
CompletedAugust 31, 2020
March 1, 2018
6 months
March 28, 2016
August 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
adverse events, clinical chemistry and hematology, pelvic exams
Day 28 - 35
Secondary Outcomes (6)
Change in Vulvovaginal Scoring System
Day 7 (+/- 2days)
Change in Vulvovaginal Scoring System
Day 14 (+/- 2days)
Change in Vulvovaginal Scoring System
Day 28 - 35
Mycological Culture
Day 7 (+/- 2days)
Mycological Culture
Day 14 (+/- 2days)
- +1 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALCD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.
Cohort 2
EXPERIMENTALCD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.
Cohort 3
ACTIVE COMPARATOROral fluconazole (150mg) administered on day 1.
Interventions
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
CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
Eligibility Criteria
You may qualify if:
- moderate to severe acute vulvovaginal candidiasis (severity score \>7)
- positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
- vaginal pH \<4.5 for subjects with positive potassium hydroxide wet preparation
- able to give written informed consent
You may not qualify if:
- receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
- known or suspected infectious causes of vulvovaginitis other than candidiasis
- history of genital herpes
- planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
- need for non-protocol systemic or vaginal antifungal therapy
- history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
- pregnant females
- females who are breast feeding
- women intending to become pregnant during the study period
- recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
- subjects who use or anticipate use of intravaginal products
- have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Precision Trials AZ LLC
Phoenix, Arizona, 85032, United States
The Women's Clinical, P.A.
Little Rock, Arkansas, 72205, United States
Women's Health Care Research Corp
San Diego, California, 92111, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
Women's Medical Research
Clearwater, Florida, 33759, United States
Altus Research Inc
Lake Worth, Florida, 33461, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Augusta University
Augusta, Georgia, 30912, United States
Clinical Trials Management LLC
Metairie, Louisiana, 70006, United States
Tolan Park Clinic
Detroit, Michigan, 48201, United States
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, 48604, United States
Lawrence OB GYN Clinical Research LLC
Lawrenceville, New Jersey, 08648, United States
Alliance Women's Research Group LLC
Riverside Park, New Jersey, 08075, United States
ProHEALTH Care Associates, LLP
Port Jefferson, New York, 11777, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Hawthorne Medical Research Inc
Winston-Salem, North Carolina, 27103, United States
Unified Women's Clinical Research - Hickory
Winston-Salem, North Carolina, 27103, United States
Aventiv Research Inc
Columbus, Ohio, 43123, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
TMC Life Research Inc.
Houston, Texas, 77054, United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229, United States
Tidewater Clinical Research, Inc
Norfolk, Virginia, 23502, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alena Jandourek, MD
Cidara Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Sponsor blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2016
First Posted
April 11, 2016
Study Start
June 8, 2016
Primary Completion
November 23, 2016
Study Completion
December 23, 2016
Last Updated
August 31, 2020
Record last verified: 2018-03