Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Advanced Urology Medical Center
Anaheim, California, United States
South Orange County Medical Research Center
Laguna Woods, California, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States
Time to Meet Insufficient Testosterone Response
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time frame: 3 months
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
Time frame: 28 days
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
Time frame: 1, 3, 7, 14, 21, 28, 42 days
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Time frame: 3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Time frame: 3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
Western Clinical Research
Torrance, California, United States
Urology Associate PC'
Denver, Colorado, United States
SW Florida Urological Associates
Fort Myers, Florida, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, United States
Drs. Werner, Murdock & Francis, PA
Greenbelt, Maryland, United States
Nevada Urology Associates
Reno, Nevada, United States
Urology Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, United States
...and 2 more locations
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Time frame: 3 months
Liver Function Tests
The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Time frame: 3 months