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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00468286 |
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Date of registration:
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13/04/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
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Scientific title:
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An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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133 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00468286 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Czech Republic
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Hungary
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Romania
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United States
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Contacts
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Name:
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Clinical Development Support |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion / Exclusion Criteria:
- Patients, aged 18 years or older, with histologically proven prostate cancer of all
stages in whom endocrine treatment is indicated.
- Screening testosterone level above the lower limit of normal range, globally defined
as >2.2 ng/mL.
- Eastern Cooperative Oncology Group (ECOG) score of =2.
- Screening prostate-specific antigen (PSA) level = ng/mL.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: Degarelix
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Primary Outcome(s)
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Probability of Testosterone at Castration Level (=0.5 ng/mL) From Day 28 Through Day 364
[Time Frame: 1 year]
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Secondary Outcome(s)
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Serum Levels of Luteinizing Hormone (LH) Over Time
[Time Frame: 1 year]
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Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
[Time Frame: Baseline up to 1 year]
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Serum Levels of Testosterone Over Time
[Time Frame: 1 year]
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Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
[Time Frame: 1 year]
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Serum Levels of PSA Over Time
[Time Frame: 1 year]
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Probability of Testosterone at Castration Level (=0.5 ng/mL) From Day 56 Through Day 364
[Time Frame: 1 year]
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Liver Function Tests
[Time Frame: 1 year]
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Probability of no PSA Failure
[Time Frame: 1 year]
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Secondary ID(s)
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FE200486 CS18
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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