Not Signed In -
Erectile Dysfunction |
ED; Erectile Disorder; Erectile Disorder (Impotence) |
Clinical Trial: A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction after Radical Prostatectomy
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Erectile Dysfunction Prostate Cancer | Drug: Prograf (FK506, tacrolimus) | Phase IV |
MedlinePlus related topics: Erectile Dysfunction; Prostate Cancer
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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
Secondary Outcomes: The percentage of patients achieving normal spontaneous erectile function
Expected Total Enrollment: 208
Study start: February 2005; Expected completion: May 2009
Last follow-up: May 2008; Data entry closure: November 2008
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
Ages Eligible for Study: up to 65 Years, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.
Exclusion Criteria:
- 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
Location and Contact Information
Ohio
The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 23, 2005
Record first received: March 23, 2005
ClinicalTrials.gov Identifier: NCT00106392
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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