NCT03646162

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Veru Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Veru-944	Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-09-14
• Primary completion: 2020-04-30
• Completion: 2020-10-15
• First posted: 2018-08-24
• Last updated: 2021-12-03
• Results posted: 2021-06-18

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study