A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in
the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Erectile Function Domain Score Between Treated and Untreated Groups
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
Astellas Pharma US, Inc.
United States: Institutional Review Board
|Albany, New York 12208|
|Cleveland, Ohio 44195|
|Nashville, Tennessee 37203-1632|
|Austin, Texas 78705|
|Flint, Michigan 48532|