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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Erectile Function Domain Score Between Treated and Untreated Groups

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma US, Inc.

Authority:

United States: Institutional Review Board

Study ID:

20-03-001

NCT ID:

NCT00106392

Start Date:

February 2005

Completion Date:

November 2008

Related Keywords:

• Erectile Dysfunction
• Prostate Cancer
• Treatment effectiveness
• Treatment efficacy
• Investigational, Therapies
• Immunosuppressant
• Erectile dysfunction
• Prostatectomy
• Prostatic Neoplasms
• Erectile Dysfunction