Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of FE 200486 in Prostate Cancer Patients

This study is ongoing, but not recruiting participants.

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00245466

Purpose

To investigate the long-term safety and tolerability of repeated doses of FE200486 to prostate cancer patients

Condition	Intervention
Prostate Cancer	Drug: Degarelix

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of FE200486 in Prostate Cancer Patients.

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

To investigate the long-term safety and tolerability of repeated doses of FE200486 to prostate cancer patients.

Secondary Outcome Measures:

To investigate the long-term response with respect to testosterone suppression after repeated doses of FE200486 in prostate cancer patients.
To investigate the long-term response with respect to 5-alpha-dihydrotestosterone (DHT), luteinizing hormone (LH), follicle stimulating hormone (FSH) and prostate-specific antigen (PSA) after repeat doses of FE200486.
To investigate the population pharmacokinetic and pharmacodynamic relationship in terms of testosterone suppression after repeated doses of FE200486.

Estimated Enrollment:

120

Eligibility

Criteria

Has completed study treatment in study FE200486 CS02.
Has completed visit 16 in study FE200486 CS02.
Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245466

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Principal Investigator:

John Hammond

Ferring Pharmaceuticals

More Information

Study ID Numbers:	FE200486 CS02A
Study First Received:	October 26, 2005
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00245466
Health Authority:	United Kingdom: National Health Service

Keywords provided by Ferring Pharmaceuticals:

Prostate Cancer
Androgen ablation therapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009