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

NCT03646162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-12-03

Study results available
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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

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

Veru-944

Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Veru Inc.

    lead INDUSTRY

Principal Investigators

  • Barnette · Veru Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2020-04-30
Completion
2020-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646162 on ClinicalTrials.gov