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Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00117949
First received: June 30, 2005
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
Results First Received: January 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Degarelix

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Degarelix 40 mg Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg Degarelix 160 mg (40 mg/mL)

Participant Flow:   Overall Study
    Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg
STARTED   10 [1]   24   24   24 
COMPLETED   0   0   0   0 
NOT COMPLETED   10   24   24   24 
Testosterone >1.0 ng/mL                10                18                17                15 
Testosterone 0.5 - 1.0 ng/mL                0                1                3                2 
Prostate-specific antigen increase >=25%                0                1                1                2 
PSA increase >=10ng/mL                0                1                1                0 
PSA reduction <=50%                0                2                2                4 
Hepatic abnormalities                0                1                0                1 
[1] Dose level terminated prematurely due to inadequate testosterone response



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Time to Meet Insufficient Testosterone Response   [ Time Frame: 3 months ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days   [ Time Frame: 28 days ]
  Show Outcome Measure 2

3.  Secondary:   Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).   [ Time Frame: 1, 3, 7, 14, 21, 28, 42 days ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days   [ Time Frame: 3 months ]
  Show Outcome Measure 4

5.  Secondary:   Time to 50% Reduction in Prostate-specific Antigen Levels   [ Time Frame: 3 months ]
  Show Outcome Measure 5

6.  Secondary:   Time to 90% Reduction in Prostate-specific Antigen Levels   [ Time Frame: 3 months ]
  Show Outcome Measure 6

7.  Secondary:   Liver Function Tests   [ Time Frame: 3 months ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com



Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00117949     History of Changes
Other Study ID Numbers: FE200486 CS06
Study First Received: June 30, 2005
Results First Received: January 22, 2009
Last Updated: May 18, 2011