drugset / Trial / NCT05605964
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-01-28
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Leuprolide | Other / unclassified | 22.5 mg | Subcutaneous |
| Comparator | Leuprolide | Other / unclassified | 45 mg | Subcutaneous |
| Subject | Relugolix | Small molecule | 120 mg | Oral |