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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 ResearchSan Antonio, Texas  78229
South Florida Medical ResearchAventura, Florida  33180
Urology Centers Of AlabamaHomewood,, Alabama  35205
Regional UrologyShreveport, Louisiana  71106
South Orange County Medical Research CenterLaguna Hills, California  92653
Lawrenceville UrologyLawrenceville, New Jersey  08648
Western Clinical ResearchTorrance, California  90505
State College Urologic AssociationState College, Pennsylvania  16801
Investigational SiteDurham, North Carolina  27710
Investigational SiteNew York, New York  10032
Urology Associates ResearchEnglewood, Colorado  
Investigational SiteOcala, Florida  
North Urology ResearchConcord, North Carolina  
Seattle Urology Research CenterBurien, Washington