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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

Interventions

Veru-944
Placebo

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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