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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
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
  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:

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
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:
Erectile Dysfunction
Prostatic Hyperplasia
Hypertrophy
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 May 22, 2013