Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
- Registration Number
- NCT03646162
- Lead Sponsor
- Veru Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 93
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Veru-944 50 mg Veru-944 Veru-944 50 mg daily Veru-944 10 mg Veru-944 Veru-944 10 mg daily Placebo Placebo Placebo daily
- Primary Outcome Measures
Name Time Method Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks 6 weeks Percentage of change in frequency of moderate to severe hot flashes at 6 weeks
- Secondary Outcome Measures
Name Time Method Change in Bone Turnover Markers C-telopeptide (CTX) 84 days Change in C-telopeptide concentration at day 84 compared to baseline
Change in Bone Turnover Markers Alkaline Phosphatase 84 days Change in bone specific alkaline phosphatase at day 84 compared to baseline
Change in Severity of Moderate to Severe Hot Flashes at Week 12 Week 12 Mean change in severity of moderate to severe hot flashes compared to baseline at week 12
Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks 6 weeks Change in severity of moderate to severe hot flashes compared to baseline at 6 weeks
Change of Frequency of Moderate to Severe Hot Flashes at Week 12 Weeks 12 Mean change in frequency of moderate to severe hot flashes compared to baseline at weeks 12
Related Research Topics
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Trial Locations
- Locations (24)
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Houston Urology Partners
🇺🇸Houston, Texas, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Urology of San Bernardino
🇺🇸San Bernardino, California, 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
Advance Urology
🇺🇸Elmont, New York, United States
Premier Urology Group
🇺🇸Edison, New Jersey, 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
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Universal Axon Clinical Research
🇺🇸Doral, Florida, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Foothills Urology
🇺🇸Golden, Colorado, United States
Gen1 Research
🇺🇸Glendale, Arizona, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Medical Research Center
🇺🇸Miami, Florida, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States