RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections
NCT ID: NCT02733432
Last Updated: 2020-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2016-06-08
2016-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
CD101 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.
CD101 Vaginal Gel (3%)
CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
CD101 External gel (1%)
CD101 external gel (1%) applied topically twice daily over 72 hours as needed
Cohort 2
CD101 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.
CD101 Vaginal Ointment (6%)
CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
CD101 External ointment (1%)
CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
Cohort 3
Oral fluconazole (150mg) administered on day 1.
Fluconazole
oral fluconazole (150mg) on Day 1
Interventions
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CD101 Vaginal Gel (3%)
CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
CD101 External gel (1%)
CD101 external gel (1%) applied topically twice daily over 72 hours as needed
CD101 Vaginal Ointment (6%)
CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
CD101 External ointment (1%)
CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
Fluconazole
oral fluconazole (150mg) on Day 1
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Cidara Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alena Jandourek, MD
Role: STUDY_DIRECTOR
Cidara Therapeutics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Tolan Park Clinic
Detroit, Michigan, United States
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, United States
Lawrence OB GYN Clinical Research LLC
Lawrenceville, New Jersey, United States
Alliance Women's Research Group LLC
Riverside Park, New Jersey, United States
ProHEALTH Care Associates, LLP
Port Jefferson, New York, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Hawthorne Medical Research Inc
Winston-Salem, North Carolina, United States
Unified Women's Clinical Research - Hickory
Winston-Salem, North Carolina, United States
Aventiv Research Inc
Columbus, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
TMC Life Research Inc.
Houston, Texas, United States
Clinical Trials of Texas Inc
San Antonio, Texas, United States
Tidewater Clinical Research, Inc
Norfolk, Virginia, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, United States
Countries
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Other Identifiers
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CD101.TP.2.01
Identifier Type: -
Identifier Source: org_study_id
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