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NCT03085095 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
A Phase 3 study, sponsored by Myovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,134
- Enrollment target
NCT03085095 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 1,134 participants.
The verdict
NCT03085095, a Phase 3 study, has completed, sponsored by Myovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,134 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.
Interventions
- DRUG Relugolix
- DRUG Leuprolide Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,134 participants |
| Start Date | 2017-04-18 |
| Est. Completion | 2021-11-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03085095
The ClinicalTrials.gov registry entry for NCT03085095 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Myovant Sciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Relugolix is the first listed.
NCT03085095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03085095 about?
NCT03085095 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer". The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.
What is the current status of trial NCT03085095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,134 participants. The study started on 2017-04-18. Estimated completion is 2021-11-26.
What interventions are being tested in trial NCT03085095?
The interventions under investigation include: Relugolix (DRUG), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT03085095?
This trial is sponsored by Myovant Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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