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

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 Overview

• Status: Completed
• Conditions: Erectile Dysfunction; BPH
• Intervention / Treatment: Drug: Alfuzosin 10 mg

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the medication on erection maintenance

Secondary Outcome Measures

Outcome Measure
Assess effect of Uroxatral on BPH and sexual function using questionnaires

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Sanofi
• Investigators: Principal Investigator: Allen D Seftel, MD, University Urologists of Cleveland

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): May 8, 2007
• Study Completion (Actual): May 8, 2007

Study Registration Dates

• First Submitted: November 18, 2005
• First Submitted That Met QC Criteria: November 18, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Prostatic Diseases; Pathological Conditions, Anatomical; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Prostatic Hyperplasia; Erectile Dysfunction; Hypertrophy; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Alfuzosin
• Other Study ID Numbers: L-9835