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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: Completed Phase 3 study, sponsored by Myovant Sciences.
NCT03085095 is a Phase 3 study that has completed, run by Myovant Sciences. The registered enrollment target is 1,134 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sustained castration rate defined as the cumulative probability of testosterone suppression to \< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.
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 |
What the finished NCT03085095 record still lists
NCT03085095 is an interventional study that assigns participants to a tested intervention. Its 1,134 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Relugolix is the first listed.
NCT03085095 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03085095's enrollment target sits among peer trials
1,134 244th of 2000 higher than 1,757 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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