Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009672

Trial Description

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Title

An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486
CS21A study. The study continued until all non-discontinued participants had received
treatment for at least 5 years.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00009672
  •   2015/11/11
  •   2007/03/23
  •   no
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Secondary IDs

  •   2006-006913-34 
  •   NCT00451958  (ClinicalTrials.gov)
  •   FE200486 CS21A  (Ferring Pharmaceuticals)
  •   2006-006913-34 
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Degarelix 80 mg / Degarelix 80 mg
  •   Drug: Degarelix 160 mg / Degarelix 160 mg
  •   Drug: Leuprolide 7.5 mg / Degarelix 80 mg
  •   Drug: Leuprolide 7.5 mg / Degarelix 160 mg
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Other
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight; time frame: Up to 4 years of treatment; This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables; time frame: Up to 4 years of treatment; This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.

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Secondary Outcome

- Percentage of Participants With no Prostate-specific Antigen (PSA) Progression; time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months; PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
- Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards; time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months; The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.
In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.
- Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56; time frame: From time of switch to Day 56
- Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56; time frame: From time of switch to Day 56
- Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56; time frame: From time of switch to Day 56
- Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56; time frame: From time of switch to Day 56

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Countries of Recruitment

  •   Canada
  •   Czech Republic
  •   Germany
  •   Hungary
  •   Mexico
  •   Netherlands
  •   Puerto Rico
  •   Romania
  •   Russian Federation
  •   Ukraine
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

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  •   2007/03/31
  •   386
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.

- Signed informed consent

- The patients must have completed the FE 200486 CS21 Study.

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Exclusion Criteria

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Addresses

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    • Ferring Pharmaceuticals
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.