MedTrace Logo

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

NCT03085095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1134

Last updated 2022-01-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.

Conditions

Interventions

DRUG

Relugolix

Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

DRUG

Leuprolide Acetate

Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection

Sponsors & Collaborators

  • Myovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Myovant Medical Monitor · Myovant Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2019-10-25
Completion
2021-11-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03085095 on ClinicalTrials.gov