Spots Global Cancer Trial Database for Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
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Trial Identification
Brief Title: Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
Official Title: Randomized, Double-blind, Placebo Controlled, Dose Finding Phase 2 Study Comparing Oral Daily Dosing of VERU-944 to Ameliorate the Vasomotor Symptoms Resulting From ADT in Men With Advanced Prostate Cancer
Study ID: NCT03646162
Conditions
Study Description
Brief Summary: Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer
Detailed Description: This study is a multicenter, randomized, double-blind, placebo controlled, dose finding study of VERU-944 to treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT. The study will have four arms with 30 subjects per arm. The subjects participating in the study will have advanced prostate cancer and will be undergoing androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone (LHRH) therapy (agonist or antagonist) for at least the three months prior to randomization and be experiencing regular moderate to severe hot flashes while on ADT. Subjects will all continue to receive ADT and will be randomized to receive, for the first four days, a loading dose followed by daily doses of placebo or VERU-944 (10 mg, 50 mg or 100 mg) orally for a total period of 12 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Gen1 Research, Glendale, Arizona, United States
Tower Urology, Los Angeles, California, United States
Urology of San Bernardino, San Bernardino, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Foothills Urology, Golden, Colorado, United States
Universal Axon Clinical Research, Doral, Florida, United States
Medical Research Center, Miami, Florida, United States
North Idaho Urology, Coeur d'Alene, Idaho, United States
First Urology, Jeffersonville, Indiana, United States
Regional Urology LLC, Shreveport, Louisiana, United States
Chesapeake Urology, Towson, Maryland, United States
Coastal Urology, Brick, New Jersey, United States
Premier Urology Group, Edison, New Jersey, United States
Advance Urology, Elmont, New York, United States
AccuMed Research, Garden City, New York, United States
Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States
Associated Medical Professionals, Syracuse, New York, United States
Clinical Research Solutions, Middleburg Heights, Ohio, United States
Urologic Consultants, Bala-Cynwyd, Pennsylvania, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Urology Clinics of North Texas, Dallas, Texas, United States
Houston Urology Partners, Houston, Texas, United States
Urology San Antonio, San Antonio, Texas, United States
Urology of Virginia, Virginia Beach, Virginia, United States
Contact Details
Name: Barnette
Affiliation: Veru Inc.
Role: STUDY_CHAIR
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