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A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients
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 Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Ayr Hospital
Ayr, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
St. Richards Hospital
Chichester, United Kingdom
Glan Clwyd Hospital
Denbighshire, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Start Date
March 1, 2001
Primary Completion Date
May 1, 2002
Completion Date
August 1, 2002
Last Updated
November 9, 2023
129
ACTUAL participants
Degarelix
DRUG
Lead Sponsor
Ferring Pharmaceuticals
NCT05691465
NCT04550494
Data Source & Attribution
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