Phase 3
Completed N=57
Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00117286 ↗Enrolled (actual)
57
Serious AEs
31.6%
Results posted
Oct 2010
Primary outcomePrimary: Participants With Markedly Abnormal Change in Vital Signs and Body Weight — 9; 4; 3; 3 participants
Summary
This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Markedly Abnormal Change in Vital Signs and Body Weight |
9; 4; 3; 3; 3; 7 | — |
| PRIMARY Liver Function Tests |
8; 11; 5; 4; 7; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
- Has completed study FE200486 CS14 through visit 22.
Exclusion Criterion:
- Has been withdrawn from the FE200486 CS14 study.
Data sourced from ClinicalTrials.gov (NCT00117286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.