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

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ClinicalTrials.gov Identifier: NCT00256399
Recruitment Status : Unknown
Verified November 2005 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
First Posted : November 21, 2005
Last Update Posted : November 27, 2007
Information provided by:
University Hospitals Cleveland Medical Center

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

Condition or disease Intervention/treatment
BPH Erectile Dysfunction 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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluate the medication on erection maintenance

Secondary Outcome Measures :
  1. Assess effect of Uroxatral on BPH and sexual function using questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256399

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 Cleveland Medical Center
Principal Investigator: Allen D Seftel, MD University Urologists of Cleveland

ClinicalTrials.gov Identifier: NCT00256399     History of Changes
Other Study ID Numbers: L-9835
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2005

Additional relevant MeSH terms:
Erectile Dysfunction
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents