At a glance
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An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 172 participants across 30 sites in 7 countries.
Detailed Summary
The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.
Study Details
Timeline
Interventions
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection