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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: |
NCT00268892 |
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Date of registration:
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21/12/2005 |
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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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Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
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Scientific title:
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An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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278 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00268892 |
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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/Phase 3
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Countries of recruitment
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Belgium
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Finland
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France
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Germany
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Montenegro
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Netherlands
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Romania
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Russian Federation
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Serbia
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United Kingdom
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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 Criteria:
- Has given written consent prior to any study-related activity is performed. A
study-related activity is defined as any procedure that would not have been performed
during the normal management of the patient.
- Has successfully completed the main study.
Exclusion Criterion:
- Has been withdrawn from the main study.
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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Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
[Time Frame: Baseline and up to 4.5 years]
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Liver Function Tests
[Time Frame: 4.5 years]
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Secondary ID(s)
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FE200486 CS15A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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