NCT00106392

A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Detailed description

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 prostatectomy.

Conditions

• Erectile Dysfunction
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Tacrolimus	oral
DRUG	Placebo	oral

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-04-01
• Completion: 2008-11-01
• First posted: 2005-03-24
• Last updated: 2010-11-23
• Results posted: 2010-10-28

Locations

6 sites across 1 country: United States