Clinical trial · Interventional

Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

NCT00215657CI-TRIAL-00004893terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The doses were not effective in maintaining testosterone suppression

Summary

Brief summary (as posted)

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Degarelix	Drug	Degarelix	ALIAS

Design

Arms and outcomes

Arms (8)

type
EXPERIMENTAL
label
Degarelix 120 mg (20 mg/mL)
description
Degarelix 120 mg (20 mg/mL)
interventionNames
1. Drug: Degarelix
type
EXPERIMENTAL
label
Degarelix 120 mg (40 mg/mL)
description
Degarelix 120 mg (40 mg/mL)
interventionNames
1. Drug: Degarelix
type
EXPERIMENTAL
label
Degarelix 160 mg (40 mg/mL)
description
Degarelix 160 mg (40 mg/mL)
interventionNames

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Males aged 18 or over
* Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
* Has completed Study FE200486 CS07
* Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

References

Publications (0)

Data not yet available

No reference posted for this study.