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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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