Back to results

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

Primary Purpose

BPH, Erectile Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alfuzosin 10 mg

About this trial

This is an interventional treatment trial for BPH

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

University Hospitals of Cleveland

Outcomes

Primary Outcome Measures

Evaluate the medication on erection maintenance

Secondary Outcome Measures

Assess effect of Uroxatral on BPH and sexual function using questionnaires

Full Information

NCT ID

NCT00256399

First Posted

November 18, 2005

Last Updated

August 10, 2022

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00256399

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

May 8, 2007 (Actual)

Study Completion Date

May 8, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BPH, Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alfuzosin 10 mg

Primary Outcome Measure Information:

Title

Evaluate the medication on erection maintenance

Secondary Outcome Measure Information:

Title

Assess effect of Uroxatral on BPH and sexual function using questionnaires

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen D Seftel, MD

Organizational Affiliation

University Urologists of Cleveland

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals of Cleveland

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs