Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Ferring Pharmaceuticals |
---|---|
Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00451958 |
The study will be performed at approx.80 study centres.Patients who completed the FE200486 CS21 study may enter the FD200486 CS21A study over a period of about 7mths. Each patient will be treated until discontinuation/withdrawal, degarelix is commercially available, a decision has been tkan to end the development of the compound, or the study has been terminated by sponsor or investigator for other reasons.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Degarelex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy |
Enrollment: | 386 |
Study Start Date: | March 2007 |
An extension study to evaluate long-term safety, tolerability, and efficacy of one-month dosing regimen of degarelix for treatment of prostate cancer.
Primary Objective:
To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients.
Secondary Objectives:
To evaluate testosterone response during long-term treatment with degarelix one-month dosing regimen.
To evaluate PSA response during long-term treatment with degarelix one-month dosing regimen.
To evaluate testosterone, PSA, LH, and FSH responses from the time of switch from LUPRON DEPOT® to degarelix.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion/Exclusion Criteria:
United States, New Jersey | |
Lawrencevillel Urology | |
Lawrenceville, New Jersey, United States, 08648 |
Principal Investigator: | BARRETT COWAN | UROLOGY ASSOCIATES, RESEARCH |
Study ID Numbers: | FE200486 CS21A |
Study First Received: | March 23, 2007 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00451958 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Degarelix powder and solvent for suspension for subcutaneous injection. |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |