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”

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

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin 10 mg

Primary Measures

• Evaluate the medication on erection maintenance

Secondary Measures

• Assess effect of Uroxatral on BPH and sexual function using questionnaires

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University Hospitals of Cleveland

Overall Clinical Trial Officials and Contacts

Allen D Seftel, MD Principal Investigator University Urologists of Cleveland  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00256399

Study ID Number: L-9835

ClinicalTrials.gov Identifier: NCT00256399

Health Authority: United States: Food and Drug Administration