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Tracking Information | |||||
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First Received Date † | January 7, 2009 | ||||
Last Updated Date | April 2, 2009 | ||||
Start Date † | March 2001 | ||||
Current Primary Outcome Measures † |
Number of Participants With Testosterone <0.5 Nanogram/Milliliter [ Time Frame: Weeks 1,2,4,8,12,16,20,24 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00819247 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer | ||||
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 | ||||
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 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. |
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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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Prostate Cancer | ||||
Intervention † | Drug: Degarelix | ||||
Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 129 | ||||
Completion Date | August 2002 | ||||
Primary Completion Date | May 2002 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00819247 | ||||
Responsible Party | Hjort, Director, Ferring Pharmaceuticals | ||||
Secondary IDs †† | |||||
Study Sponsor † | Ferring Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Ferring Pharmaceuticals | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |