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

Not Applicable

Completed

• Conditions: BPH; Erectile Dysfunction

• Registration Number: NCT00256399
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2005-11
• Study Start: 2005-11
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-21
• Primary Completion: 2007-05-08
• Study Completion: 2007-05-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the medication on erection maintenance

Secondary Outcome Measures

Name	Time	Method
Assess effect of Uroxatral on BPH and sexual function using questionnaires

Trial Locations

Locations (1)

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States