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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2005 by University Hospitals of Cleveland.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Sanofi-Aventis

Information provided by:

University Hospitals of Cleveland

ClinicalTrials.gov Identifier:

NCT00256399

First received: November 18, 2005

Last updated: November 26, 2007

Last verified: November 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

November 18, 2005

Last Updated Date

November 26, 2007

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Evaluate the medication on erection maintenance

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00256399 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess effect of Uroxatral on BPH and sexual function using questionnaires

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

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

Condition ^ICMJE

BPH
Erectile Dysfunction

Intervention ^ICMJE

Drug: Alfuzosin 10 mg

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Male

Ages

45 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00256399

Other Study ID Numbers ^ICMJE

L-9835

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

University Hospitals of Cleveland

Collaborators ^ICMJE

Sanofi-Aventis

Investigators ^ICMJE

Principal Investigator:

Allen D Seftel, MD

University Urologists of Cleveland

Information Provided By

University Hospitals of Cleveland

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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