Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED) - Full Text View

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

This study is currently recruiting participants.
Verified by University Hospitals of Cleveland, November 2005

Sponsors and Collaborators:	University Hospitals of Cleveland 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

MedlinePlus related topics:

Erectile Dysfunction

ChemIDplus related topics:

Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

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

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

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological

Pathological Conditions, Anatomical

Hypertrophy

Alfuzosin

Sexual Dysfunction, Physiological

Mental Disorders

Genital Diseases, Male

Erectile Dysfunction

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic Antagonists

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Sexual and Gender Disorders

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008