Phase 3
Completed N=278
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00268892 ↗Enrolled (actual)
278
Serious AEs
27.0%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight — 5; 6; 4; 7 participants
Summary
The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
5; 6; 4; 7; 6; 8 | — |
| PRIMARY Liver Function Tests |
22; 22; 17; 18; 25; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
- Has successfully completed the main study.
Exclusion Criterion:
- Has been withdrawn from the main study.
Data sourced from ClinicalTrials.gov (NCT00268892). 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.