Official Title: “Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy”

To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin

Primary Measures

• IIEF and GEQ (Global Efficacy Question)
  • Time Frame: at intermediate visit (M1) and at end-point visit(M3)
    

Secondary Measures

• blood pressure and heart rate measure in sitting position
  • Time Frame: at each visit
    
• IPSS and Quality of Life Score
  • Time Frame: at intermediate visit (M1) and at end-point visit(M3)
    
• Maximum flow rate and post voiding residual urine
  • Time Frame: at end-point visit(M3)
    
• Spontaneous reported adverse events
  • Time Frame: During all the study period
    

Inclusion Criteria:

• male patients suffering from LUTS lasting 6months and over
• male patients aged 50 years old and over who has a continuous active partner

Exclusion Criteria:

• Primary hypogonadism and neuropathy patients
• History of prostate surgery
• Patients with prostate cancer
• History of organ surgery or organ damage in pelvis
• History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
• Patients with haematuria caused by other reasons except BPH
• Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
• History of a malignant tumor within last 5 years
• Patients who are currently controlled with other medication for erectile dysfunction
• Patients who have been administered with androgen or antiandrogen
• Patients who is treated for psychiatric disorder or depression
• Combination with other alpha1-blockers
• Patients previously not improved by an alpha1-blocker treatment
• Known hypersensitivity to the alfuzosin
• History of postural hypotension or syncope
• Hepatic insufficiency
• Unstable angina pectoris
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Tae-Young Ahn Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542165

Study ID Number: L_8819

ClinicalTrials.gov Identifier: NCT00542165

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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