Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
NCT ID: NCT00215657
Last Updated: 2011-05-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
131 participants
INTERVENTIONAL
2003-03-31
2006-03-31
Brief Summary
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Detailed Description
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The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix 120 mg (20 mg/mL)
Degarelix 120 mg (20 mg/mL)
Degarelix
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 120 mg (40 mg/mL)
Degarelix 120 mg (40 mg/mL)
Degarelix
Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 160 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)
Degarelix
Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 200 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)
Degarelix
Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 200 mg (60 mg/mL)
Degarelix 200 mg (60 mg/mL)
Degarelix
Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 240 mg (40 mg/mL)
Degarelix 240 mg (40 mg/mL)
Degarelix
Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 240 mg (60 mg/mL)
Degarelix 240 mg (60 mg/mL)
Degarelix
Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 320 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)
Degarelix
Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Interventions
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Degarelix
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix
Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
* Has completed Study FE200486 CS07
* Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Ferring Pharmaceuticals
Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Other Identifiers
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FE200486 CS07A
Identifier Type: -
Identifier Source: org_study_id
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