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

First Received on November 18, 2005. Last Updated on November 26, 2007 History of Changes

Sponsor:	University Hospitals of Cleveland
Collaborator:	Sanofi-Aventis
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00256399

Purpose

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

Condition	Intervention
BPH Erectile Dysfunction	Drug: Alfuzosin 10 mg

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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Evaluate the medication on erection maintenance

Secondary Outcome Measures:

Assess effect of Uroxatral on BPH and sexual function using questionnaires

Estimated Enrollment:	100
Study Start Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256399

Locations

United States, Ohio
University Hospitals of Cleveland	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ann M Serenko, MS, RN 216-844-3515 ann.serenko@uhhs.com
Contact: Allen D Seftel, MD 216-844-7728 adseftel@aol.com
Principal Investigator: Allen D Seftel, MD
Sub-Investigator: Martin Resnick, MD
Sub-Investigator: Donald Bodner, MD

Sponsors and Collaborators

University Hospitals of Cleveland

Sanofi-Aventis

Investigators

Principal Investigator:

Allen D Seftel, MD

University Urologists of Cleveland

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00256399 History of Changes
Other Study ID Numbers:	L-9835
Study First Received:	November 18, 2005
Last Updated:	November 26, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hypertrophy
Erectile Dysfunction
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alfuzosin

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012