Clinical trial · Interventional
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.
NCT00215683CI-TRIAL-00017349completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Degarelix 80 mg
- description
- Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
- interventionNames
- Drug: Degarelix
- type
- EXPERIMENTAL
- label
- Degarelix 120 mg
- description
- Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
- interventionNames
- Drug: Degarelix
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant) * Had completed the FE200486 CS12 study Exclusion criterion: * Had been withdrawn from the FE200486 CS12 study
References
Publications (0)
Data not yet available
No reference posted for this study.