An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
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- Has been withdrawn from the FE200486 CS14 study.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 Center | Anaheim, California 92801 |
| Urology San Antonio Research | San Antonio, Texas 78229 |
| Virginia Urology Center | Richmond, Virginia 23230 |
| South Florida Medical Research | Aventura, Florida 33180 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Regional Urology | Shreveport, Louisiana 71106 |
| The Urology Center | Greensboro,, North Carolina 27401 |
| Northeast Indiana Research, LLC | Fort Wayne, Indiana 46825-1675 |
| Lawrenceville Urology | Lawrenceville, New Jersey 08648 |
| University Urological Research Institute | Providence, Rhode Island 02904 |
| Western Clinical Research | Torrance, California 90505 |
| West Coast Clinical Research | Tarzana, California 91356 |
| SW Florida Urological Associates | Fort Myers, Florida 33907 |
| State College Urologic Association | State College, Pennsylvania 16801 |
| University of Vermont, Dept of Surgery | South Burlington, Vermont 05403 |
| Urology Associate PC` | Denver, Colorado 80210 |
| Investigational site | Seattle, Washington 98166 |
