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An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer


Participants who completed the main FE200486 CS14 study initially continued with the same
dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160
mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study
(FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.


Inclusion Criteria:



- 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 Criterion:

- Has been withdrawn from the FE200486 CS14 study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Participants With Markedly Abnormal Change 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 at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

Outcome Time Frame:

5 years

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 CS14A

NCT ID:

NCT00117286

Start Date:

March 2005

Completion Date:

November 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen ablation therapy
  • Prostatic Neoplasms

Name

Location

Advanced Urology Medical CenterAnaheim, California  92801
Urology San Antonio ResearchSan Antonio, Texas  78229
Virginia Urology CenterRichmond, Virginia  23230
South Florida Medical ResearchAventura, Florida  33180
Urology Centers Of AlabamaHomewood,, Alabama  35205
Regional UrologyShreveport, Louisiana  71106
The Urology CenterGreensboro,, North Carolina  27401
Northeast Indiana Research, LLCFort Wayne, Indiana  46825-1675
Lawrenceville UrologyLawrenceville, New Jersey  08648
University Urological Research InstituteProvidence, Rhode Island  02904
Western Clinical ResearchTorrance, California  90505
West Coast Clinical ResearchTarzana, California  91356
SW Florida Urological AssociatesFort Myers, Florida  33907
State College Urologic AssociationState College, Pennsylvania  16801
University of Vermont, Dept of SurgerySouth Burlington, Vermont  05403
Urology Associate PC`Denver, Colorado  80210
Investigational siteSeattle, Washington  98166