Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer Metastatic
• Interventions: Drug: Veru-944; Drug: Placebo

• 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.

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Study Start: 2018-09-14
• Primary Completion: 2020-04-30
• Study Completion: 2020-10-15
• Results First Submitted: 2021-05-01
• Results First Submitted QC: 2021-05-24
• Results First Posted: 2021-06-18
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 93

Inclusion Criteria

Not provided

Exclusion Criteria

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
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
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

Trial Locations

Locations (24)

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

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