Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
NCT00245466
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
NCT00116779
A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
NCT00116753
A Study of Degarelix in Patients With Prostate Cancer
NCT00928434
Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
NCT00738673
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
* Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
* Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
2
* Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
* Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.
Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Screening testosterone level above the lower limit of normal range, globally defined as \> 2.2 ng/mL.
* Screening PSA level of =2 ng/mL. ECOG score of =2.
* Life expectancy of at least one year.
CRITERIA FOR EVALUATION:
Primary endpoint:
* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.
Secondary endpoints:
* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
* Serum levels of testosterone, LH, FSH, and PSA over time.
* Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
* Plasma levels of degarelix over time.
* Frequency and severity of adverse events.
* Clinically significant changes in laboratory safety parameters.
* Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ferring Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-006055-39
Identifier Type: -
Identifier Source: secondary_id
FE200486 CS26
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.