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NCT00256399 Clinical Trial

Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

Erectile Dysfunction Clinical Trial

Official title:
A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256399
Other study ID # L-9835
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2005
Est. completion date May 8, 2007

Study information
Verified date November 2005
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

Description:

The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date May 8, 2007
Est. primary completion date May 8, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - Males 45-75 years of age - Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED - Men with steady partner and who agree to attempt sex once a week. Exclusion Criteria: - Prostate cancer - Prostatitis - Penile disease - Cardiac co-morbidity - Pre-existing co-morbid conditions - History of sensitivity to the drug or similar drugs - Enrollment in another clinical trial - Impaired hepatic function - Impaired renal function - Mental conditions rendering subject unable to understand the study - Subjects not likely to comply with protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alfuzosin 10 mg

Locations
Country Name City State
United States University Hospitals of Cleveland Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the medication on erection maintenance
Secondary Assess effect of Uroxatral on BPH and sexual function using questionnaires
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