CompletedPhase 3

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

United States387 participantsStarted 2023-01-25

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Was previously enrolled under the original version and amendment 1 of this study
✓. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study

What they're measuring

Incidence of Safety Outcomes

Timeframe: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter

Trial details

NCT IDNCT05605964

SponsorSumitomo Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-02

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