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

Completed · Phase 2

Conditions studied: Candidiasis, Vulvovaginal, Mycoses, Yeast Infection, Moniliasis, Vulvovaginal, Vaginitis, Monilial

In brief

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.

Key facts

Study ID

NCT02733432

Run by

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

126

Starts

2016-06-08

Expected to finish

2016-12-23

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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