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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

Tracking Information
First Submitted Date  ICMJE November 18, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date November 27, 2007
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2005)
Evaluate the medication on erection maintenance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2005)
Assess effect of Uroxatral on BPH and sexual function using questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
Official Title  ICMJE 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
Brief Summary Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • BPH
  • Erectile Dysfunction
Intervention  ICMJE Drug: Alfuzosin 10 mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256399
Other Study ID Numbers  ICMJE L-9835
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Allen D Seftel, MD University Urologists of Cleveland
PRS Account University Hospitals Cleveland Medical Center
Verification Date November 2005

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