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Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
Plain-language guide to NCT01215513: phase 3 interventional trial of Degarelix, 127 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01215513
- Phase
- phase 3
- Status
- completed
- Start
- 2010-09
- Completion (planned or actual)
- 2012-04
- Participants
- 127 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Degarelix.
It had 1 arm (groups): Degarelix (experimental).
The registry classes the interventions as drug.
Who Took Part
127 actual participants took part.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Has completed the 7-month main trial, FE200486 CS42.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: has been withdrawn/discontinued from the fe200486 cs42 trial.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Degarelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-09 with completion listed for 2012-04.
It ran at 11 sites in South Korea (11).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables (time frame: From baseline (day 0) to end of treatment (up to day 364)). Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight (time frame: From baseline (day 0) to end of treatment (up to day 364)). Number of Participants With Markedly Abnormal Values in ECG Variables (time frame: From baseline (day 0) to end of treatment (up to day 364)).
It also tracked 1 secondary outcome, for example Serum Levels of Prostate Specific Antigen (PSA) Over Time.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Degarelix in 127 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Degarelix compound page, all human trials.
Our Notes on the Compound
Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.