Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
NCT00818623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172
Last updated 2023-11-30
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.
Conditions
Interventions
- DRUG
-
Degarelix
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
- DRUG
-
Degarelix
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Clinical Development Support · Ferring Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-11-30
- Primary Completion
- 2004-10-31
- Completion
- 2004-10-31
Countries
- Denmark
- Finland
- Hungary
- Norway
- Romania
- Russia
- Sweden
Study Locations
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