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An 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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

An 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

Inclusion Criteria


Inclusion/Exclusion Criteria:

- Patients with histologically proven prostate cancer of all stages in whom endocrine
treatment is indicated.

- Signed informed consent

- The patients must have completed the FE 200486 CS21 Study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Outcome Description:

This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.

Outcome Time Frame:

Up to 4 years of treatment

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

FE200486 CS21A

NCT ID:

NCT00451958

Start Date:

March 2007

Completion Date:

December 2011

Related Keywords:

  • Prostate Cancer
  • Degarelix
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

Urology San Antonio Research San Antonio, Texas  78229
South Florida Medical Research Aventura, Florida  33180
Urology Centers Of Alabama Homewood,, Alabama  35205
Regional Urology Shreveport, Louisiana  71106
South Orange County Medical Research Center Laguna Hills, California  92653
Lawrenceville Urology Lawrenceville, New Jersey  08648
Western Clinical Research Torrance, California  90505
State College Urologic Association State College, Pennsylvania  16801
Investigational Site Durham, North Carolina  27710
Investigational Site New York, New York  10032
Urology Associates Research Englewood, Colorado  
Investigational Site Ocala, Florida  
North Urology Research Concord, North Carolina  
Seattle Urology Research Center Burien, Washington