Status:

COMPLETED

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

Lead Sponsor:

Astellas Pharma Inc

Conditions:

Erectile Dysfunction

Prostate Cancer

Eligibility:

MALE

Up to 65 years

Phase:

PHASE4

Brief 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.

Eligibility Criteria

Inclusion

  • Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion

  • Patient is \> 65 years of age
  • Patient has been diagnosed with Type 1 or Type 2 diabetes
  • Patient is actively smoking on a daily basis

Key Trial Info

Start Date :

February 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

131 Patients enrolled

Trial Details

Trial ID

NCT00106392

Start Date

February 1 2005

End Date

November 1 2008

Last Update

November 23 2010

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Ann Arbor, Michigan, United States, 48109

2

New York, New York, United States, 10016

3

New York, New York, United States, 10021

4

Cleveland, Ohio, United States, 44195