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Clinical trial

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

Read time: 3 mins
Last updated:14th Sep 2018
Identifier: NCT03646162

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 Type: Interventional  (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date: September 14, 2018
Estimated Primary Completion Date: May 31, 2019
Estimated Study Completion Date: July 29, 2019

- Experimental:
Veru-944 10 mg
- Experimental: Veru-944 50 mg
- Experimental: Veru-944 100 mg
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-04-04
Study type(s) Interventional
Expected enrolment 120
Study start date 2018-09-14
Estimated primary completion date 2019-05-31

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