Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

NCTNCT05605964 (opens ClinicalTrials.gov in a new tab)Other idMVT-601-056
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
387 participants (actual)
Sponsor
Sumitomo Pharma America, Inc. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
28 Jan 2023
Primary completion
31 Dec 2024
Completion
31 Dec 2024
First posted
4 Nov 2022
Last update posted
15 Jun 2026
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 3

    Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

    NCT05605964

    28 Jan 2023 to 31 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.

Interventions

  • RelugolixDrug
  • Leuprolide AcetateDrug

Arms2

  • Experimental

    Relugolix

    Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1

  • Active comparator

    Leuprolide Acetate

    Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Patients With Adverse Events and Serious Adverse Events

    Time frame · Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year

    Registry description

    Number of patients with adverse events and serious adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter, up to 1 year

Number of Patients With Adverse Events and Serious Adverse Events

GroupValue (Participants)
Relugolix94
Leuprolide Acetate92

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RelugolixOral relugolix 120 mg once daily with a loading dose of 360 mg on Day 18 / 19113 / 19193 / 191
Leuprolide AcetateSubcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)7 / 1875 / 18791 / 187

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
A patient will be eligible for inclusion in the discontinuation phase of the study if the following applies: 1. Was previously enrolled under the original version and amendment 1 of this study 2. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study

PepBank is a research reference. Talk to a doctor before you use any peptide.