Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
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
Outcome
Mixed primary results
registry analysis (superiority or other test); Degarelix 40 mg vs Degarelix 80 mg vs Degarelix 120 mg vs Degarelix 160 mg; p <0.001; Log Rank NCT00117949 ↗
registry MEDIAN Degarelix 40 mg: 14 (14 to 70) days NCT00117949 ↗
registry MEDIAN Degarelix 120 mg: 98 (14 to 219) days NCT00117949 ↗
registry analysis (superiority or other test); Degarelix 40 mg vs Degarelix 80 mg vs Degarelix 120 mg vs Degarelix 160 mg; p = 0.181; Cochran-Armitage Trend Test. NCT00117949 ↗
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 |