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An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
Plain-language guide to NCT00215683: phase 2, phase 3 non-randomized trial of Degarelix, 137 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00215683
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2005-02
- Completion (planned or actual)
- 2009-10
- Participants
- 137 (actual)
- Design
- non-randomized, 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 2, phase 3 trial, researchers set out to test Degarelix.
This was an extension study for the study FE200486 CS12 (NCT00819156).
Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.
The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
More on the Plan
The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.
Who Took Part
The registry lists 137 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: Had completed the FE200486 CS12 study. Had been withdrawn from the FE200486 CS12 study.
The full record lists 3 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.
It started in 2005-02 with completion listed for 2009-10.
It ran at 34 sites in Russia (11), Hungary (7), South Africa (5), Romania (4), Belgium (3) and Germany (2).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Participants With Markedly Abnormal Change in Vital Signs and Body Weight (time frame: 5 years). Liver Function Tests (time frame: 5 years).
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, non-randomized trial of Degarelix in 137 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.