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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00819247 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Degarelix |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 129 |
Study Start Date: | March 2001 |
Study Completion Date: | August 2002 |
Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Degarelix 80/80 + 40: Experimental
Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
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Drug: Degarelix
Given as a subcutaneous injection.
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Degarelix 40/40 + 40: Experimental
Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
|
Drug: Degarelix
Given as a subcutaneous injection.
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Degarelix 80 + 20: Experimental
Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.
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Drug: Degarelix
Given as a subcutaneous injection.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Derriford Hospital | |
Plymouth, United Kingdom | |
Southmead Hospital | |
Bristol, United Kingdom | |
St. Richards Hospital | |
Chichester, United Kingdom | |
St. Bartholemews Hospital | |
London, United Kingdom | |
Lister Hospital | |
Stevenage, United Kingdom | |
Leicester General Hospital | |
Leicester, United Kingdom | |
Morriston Hospital | |
Swansea, United Kingdom | |
Pindersfields General Hospital | |
Wakefield, United Kingdom | |
Kings College Hospital | |
London, United Kingdom | |
Southern General Hospital | |
Glasgow, United Kingdom | |
Ayr Hospital | |
Ayr, United Kingdom | |
Chelsea and Westminster Hospital | |
London, United Kingdom | |
Glan Clwyd Hospital | |
Denbighshire, United Kingdom | |
Bristol Royal Infirmary | |
Bristol, United Kingdom | |
Stirling Royal Infirmary | |
Stirling, United Kingdom | |
Ninewells Hospital | |
Dundee, United Kingdom |
Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
Responsible Party: | Ferring Pharmaceuticals ( Hjort, Director ) |
Study ID Numbers: | FE200486 CS02 |
Study First Received: | January 7, 2009 |
Results First Received: | January 22, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00819247 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |