A Phase 3 interventional study of Degarelix and Degarelix in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-18.
Sponsored by Ferring Pharmaceuticals · Phase 3, Interventional, and Treatment
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
Browse Prostatic Neoplasms studies →Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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Inclusion Criteria:
CRITERIA FOR EVALUATION:
Primary endpoint:
Secondary endpoints:
* 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
Drug: Degarelix
* 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.
Drug: Degarelix
To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
Time frame: 3-month
To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
Time frame: 3-month
To evaluate pharmacokinetic response.
Time frame: 3-month
To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
Time frame: 3-month
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Degarelix