drugset / Trial / NCT00117949
Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
RandomizedParallel-groupOpen-labelTreatment
Summary
Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.
Timeline
- Start
- 2002-04
- Primary completion
- 2004-01
- Completion
- 2004-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Degarelix | Other / unclassified | 40 mg | Subcutaneous |
| Subject | Degarelix | Other / unclassified | 80 mg | Subcutaneous |
| Subject | Degarelix | Other / unclassified | 120 mg | Subcutaneous |
| Subject | Degarelix | Other / unclassified | 160 mg | Subcutaneous |