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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• BPH
• Erectile Dysfunction
• Hypertrophy
• Prostatic Hyperplasia

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