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NCT02083185 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
A Phase 2 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
NCT02083185: Completed Phase 2 study, sponsored by Millennium Pharmaceuticals.
NCT02083185 is a Phase 2 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02083185, a Phase 2 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).
Primary Outcome
Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits beginning after 4 weeks of treatment.
Interventions
- DRUG Relugolix
- DRUG Leuprorelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-03-26 |
| Est. Completion | 2017-02-23 |
| Phase | Phase 2 |
What the finished NCT02083185 record still lists
NCT02083185 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Relugolix is the first listed.
NCT02083185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02083185 about?
NCT02083185 is a clinical study titled "A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer". The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).
What is the current status of trial NCT02083185?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2014-03-26. Estimated completion is 2017-02-23.
What interventions are being tested in trial NCT02083185?
The interventions under investigation include: Relugolix (DRUG), Leuprorelin (DRUG).
Who is sponsoring clinical trial NCT02083185?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02083185's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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