At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 136 enrolled
Drug / intervention
Relugolix +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of the Oral GnRH Antagonist TAK-385, Together With a Leuprorelin Observational Cohort, in Patients With Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Relugolix and Leuprorelin for Prostate Cancer. Completed, enrolled 136 participants across 23 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMar 2014
Primary CompletionJan 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedMar 11, 2014
Enrollment StartMar 26, 2014
Primary CompletionJan 1, 2016
Study CompletionFeb 23, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.3 years ago
Interventions
Relugolixdrug
Relugolix tablets
Leuprorelindrug
Leuprorelin subcutaneous injection