Phase 3
Completed N=137
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
Source: ClinicalTrials.gov NCT00215683 ↗Enrolled (actual)
137
Serious AEs
35.8%
Results posted
Dec 2010
Primary outcomePrimary: Participants With Markedly Abnormal Change in Vital Signs and Body Weight — 3; 5; 10; 9 participants
Summary
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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Markedly Abnormal Change in Vital Signs and Body Weight |
3; 5; 10; 9; 5; 9 | — |
| PRIMARY Liver Function Tests |
19; 18; 23; 18; 23; 21 | — |
Eligibility Criteria
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- Had been withdrawn from the FE200486 CS12 study
Data sourced from ClinicalTrials.gov (NCT00215683). 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.