Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117286

Purpose

This is an extension study for the study FE200486 CS14. Each patient will be treated until patients are discontinued, withdrawn from the study, or a marketing authorization for degarelix has been obtained.

Condition	Intervention
Prostate Cancer	Drug: Degarelix

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

To demonstrate the efficacy of degarelix to evaluate safety and tolerability

Secondary Outcome Measures:

To evaluate the pharmacokinetics and safety of degarelix

Enrollment:	57
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
Has completed study FE200486 CS14 through Visit 22.

Exclusion Criteria:

Any patient meeting the following exclusion criteria will not be entered into the study:

Has been withdrawn from the FE200486 CS14 study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117286

Show 24 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

More Information

Study ID Numbers:	FE200486 CS14A
Study First Received:	June 30, 2005
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00117286
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

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 14, 2009