drugset / Trial / NCT02083185
A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).
Timeline
- Start
- 2014-03-26
- Primary completion
- 2016-01-01
- Completion
- 2017-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Leuprolide | Other / unclassified | 22.5 mg | Subcutaneous |
| Subject | Relugolix | Small molecule | 80 mg | Oral |
| Subject | Relugolix | Small molecule | 120 mg | Oral |