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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
Sponsor:
Collaborator:
Sanofi
Information provided by:
University Hospitals Cleveland Medical Center

November 18, 2005
November 21, 2005
November 27, 2007
November 2005
Not Provided
Evaluate the medication on erection maintenance
Same as current
Complete list of historical versions of study NCT00256399 on ClinicalTrials.gov Archive Site
Assess effect of Uroxatral on BPH and sexual function using questionnaires
Same as current
Not Provided
Not Provided
 
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
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
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • BPH
  • Erectile Dysfunction
Drug: Alfuzosin 10 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
Same as current
Not Provided
Not Provided

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
Sexes Eligible for Study: Male
45 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00256399
L-9835
Not Provided
Not Provided
Not Provided
Not Provided
University Hospitals Cleveland Medical Center
Sanofi
Principal Investigator: Allen D Seftel, MD University Urologists of Cleveland
University Hospitals Cleveland Medical Center
November 2005

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