drugset / Trial / NCT00831233

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

NCT00831233

Phase 3 Terminated 42 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Timeline

Start
2009-04
Primary completion
2010-06
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Degarelix Other / unclassified 80 mg Subcutaneous
Comparator Goserelin Other / unclassified 3.6 mg Subcutaneous
Comparator Bicalutamide Other / unclassified 50 mg Oral

Indications