Status:
COMPLETED
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for ...
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Eligibility Criteria
Inclusion
- Signed informed consent before any trial related activity
- Proven prostate cancer with a need for endocrine treatment
- Testosterone level within the normal range for the age
Exclusion
- Previous or current hormonal treatment of prostate cancer
- Candidate for prostatectomy or radiotherapy
- History of severe asthma, anaphylactic reactions or Quincke's Oedema
- Hypersensitivity towards any component of FE200486
- Cancer disease within the last ten years except for prostate cancer and some skin cancers
- Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
- Mental incapacity or language barrier
- Having received an investigational product within the last 12 weeks preceding the trial
- Previous participation in this trial
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2002
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00819247
Start Date
March 1 2001
End Date
August 1 2002
Last Update
November 9 2023
Active Locations (16)
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1
Ayr Hospital
Ayr, United Kingdom
2
Bristol Royal Infirmary
Bristol, United Kingdom
3
Southmead Hospital
Bristol, United Kingdom
4
St. Richards Hospital
Chichester, United Kingdom