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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
  Hide Participant Flow

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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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)
Total Total of all reporting groups

Baseline Measures
   Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 10   24   24   24   82 
Age 
[Units: Participants]
 		         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   1   1   2   4   8 
>=65 years   9   23   22   20   74 
Age 
[Units: Years]
Mean (Standard Deviation) 		 72.0  (5.7)   77.5  (6.4)   75.9  (5.8)   74.7  (8.4)   75.6  (6.9) 
Gender 
[Units: Participants]
 		         
Female   0   0   0   0   0 
Male   10   24   24   24   82 
Race/Ethnicity, Customized 
[Units: Participants]
 		         
Oriental/Asian   0   0   0   0   0 
Black   2   1   2   1   6 
Caucasian   5   23   15   20   63 
Other   3   0   7   3   13 
Gleason score [1] 
[Units: Participants]
 		         
Unknown   0   1   0   0   1 
2-4   1   1   1   0   3 
5-6   3   14   12   13   42 
7-10   6   8   11   11   36 
[1] The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.
Stage of prostate cancer [1] 
[Units: Participants]
 		         
Localized   5   11   12   10   38 
Locally advanced   0   6   5   5   16 
Metastatic   2   4   2   2   10 
Not classifiable   3   3   5   7   18 
[1] Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Body mass index [1] 
[Units: Kilogram per square meter]
Mean (Standard Deviation) 		 26.70  (5.72)   26.61  (3.55)   27.22  (3.16)   26.64  (3.38)   26.70  (5.72) 
[1] Body mass index is a measure of body fat based on height and weight.
Serum prostate-specific antigen levels 
[Units: Nanogram per milliliter]
Median (Full Range) 		 9.30 
 (2.3 to 36.3)  		 13.40 
 (3.6 to 765)  		 9.10 
 (2.2 to 50.9)  		 6.40 
 (2.2 to 154)  		 9.35 
 (2.2 to 765) 
Serum testosterone levels 
[Units: Nanogram per milliliter]
Median (Full Range) 		 3.98 
 (2.29 to 5.31)  		 4.10 
 (1.79 to 8.53)  		 3.96 
 (2.02 to 7.22)  		 3.89 
 (1.79 to 8.53)  		 3.93 
 (1.79 to 8.53) 
Time since prostate cancer diagnosis [1] 
[Units: Days]
Mean (Standard Deviation) 		 851  (1077)   954  (1328)   1609  (1836)   1095  (1385)   1181  (1494) 
[1] The mean number of days since a diagnosis of prostate cancer was made for the patients in each study group.
Weight 
[Units: Kilogram]
Mean (Standard Deviation) 		 78.97  (11.73)   81.73  (11.50)   80.77  (12.83)   81.40  (14.36)   81.01  (12.61) 


  Outcome Measures
  Show All Outcome Measures

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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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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)

Other Adverse Events
    Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg
Total, Other (not including serious) Adverse Events         
# participants affected   6   18   20   13 
Blood and lymphatic system disorders         
Anaemia † 1         
# participants affected / at risk   0/10 (0.00%)   0/24 (0.00%)   3/24 (12.50%)   0/24 (0.00%) 
# events   0   0   4   0 
Eye disorders         
Diabetic retinopathy † 1         
# participants affected / at risk   1/10 (10.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
# events   1   0   0   0 
Gastrointestinal disorders         
Diarrhoea † 1         
# participants affected / at risk   0/10 (0.00%)   1/24 (4.17%)   2/24 (8.33%)   0/24 (0.00%) 
# events   0   1   2   0 
Constipation † 1         
# participants affected / at risk   0/10 (0.00%)   0/24 (0.00%)   2/24 (8.33%)   0/24 (0.00%) 
# events   0   0   2   0 
Haemorrhoids † 1         
# participants affected / at risk   0/10 (0.00%)   0/24 (0.00%)   2/24 (8.33%)   0/24 (0.00%) 
# events   0   0   2   0 
Inguinal hernia † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   0/24 (0.00%)   0/24 (0.00%) 
# events   0   2   0   0 
General disorders         
Injection site pain † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   3/24 (12.50%)   1/24 (4.17%) 
# events   0   2   4   1 
Fatigue † 1         
# participants affected / at risk   1/10 (10.00%)   2/24 (8.33%)   0/24 (0.00%)   2/24 (8.33%) 
# events   1   2   0   2 
Injection site pruritus † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   1/24 (4.17%)   0/24 (0.00%) 
# events   0   2   1   0 
Chest pain † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   0/24 (0.00%)   0/24 (0.00%) 
# events   0   4   0   0 
Infections and infestations         
Nasopharyngitis † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   3/24 (12.50%)   1/24 (4.17%) 
# events   0   2   3   1 
Investigations         
Alanine aminotransferase increased † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   0/24 (0.00%)   0/24 (0.00%) 
# events   0   2   0   0 
Aspartate aminotransferase increased † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   0/24 (0.00%)   0/24 (0.00%) 
# events   0   2   0   0 
Breath sounds abnormal † 1         
# participants affected / at risk   1/10 (10.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
# events   1   0   0   0 
Musculoskeletal and connective tissue disorders         
Back pain † 1         
# participants affected / at risk   1/10 (10.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
# events   1   0   0   0 
Osteoarthritis † 1         
# participants affected / at risk   1/10 (10.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
# events   1   0   0   0 
Nervous system disorders         
Dizziness † 1         
# participants affected / at risk   1/10 (10.00%)   2/24 (8.33%)   2/24 (8.33%)   1/24 (4.17%) 
# events   1   2   2   1 
Headache † 1         
# participants affected / at risk   1/10 (10.00%)   1/24 (4.17%)   2/24 (8.33%)   0/24 (0.00%) 
# events   1   1   2   0 
Psychiatric disorders         
Libido decreased † 1         
# participants affected / at risk   0/10 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   2/24 (8.33%) 
# events   0   0   0   2 
Renal and urinary disorders         
Dysuria † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   1/24 (4.17%)   1/24 (4.17%) 
# events   0   2   1   1 
Urinary retention † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   0/24 (0.00%)   0/24 (0.00%) 
# events   0   2   0   0 
Urine flow decreased † 1         
# participants affected / at risk   1/10 (10.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
# events   1   0   0   0 
Respiratory, thoracic and mediastinal disorders         
Cough † 1         
# participants affected / at risk   0/10 (0.00%)   0/24 (0.00%)   2/24 (8.33%)   0/24 (0.00%) 
# events   0   0   2   0 
Skin and subcutaneous tissue disorders         
Pruritus † 1         
# participants affected / at risk   0/10 (0.00%)   2/24 (8.33%)   0/24 (0.00%)   0/24 (0.00%) 
# events   0   3   0   0 
Vascular disorders         
Hot flush † 1         
# participants affected / at risk   2/10 (20.00%)   12/24 (50.00%)   5/24 (20.83%)   5/24 (20.83%) 
# events   2   12   6   5 
Hypertension † 1         
# participants affected / at risk   0/10 (0.00%)   0/24 (0.00%)   2/24 (8.33%)   0/24 (0.00%) 
# events   0   0   2   0 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 4.1



  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
No text entered.


  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