Status:
TERMINATED
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 ho...
Eligibility Criteria
Inclusion
- Patient has given written informed consent before any trial-related activity is performed
- Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
- Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
- Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00831233
Start Date
April 1 2009
End Date
July 1 2010
Last Update
November 11 2013
Active Locations (33)
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1
Facharztpraxis für Urologie
Bamberg, Germany, 96047
2
Gemeinschaftspraxis
Borken, Germany, 46325
3
Gemeinschaftspraxis
Cologne, Germany, 50667
4
Universitätsklinikum Dresden
Dresden, Germany, 01307