Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Phase 4

Completed

• Conditions: Prostatic Diseases

• Registration Number: NCT00575913
• Lead Sponsor: Sanofi

Brief Summary

To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2005-03
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-08
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 118

Inclusion Criteria

• Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.

Exclusion Criteria

• Patients requiring BPH surgery immediately or within the 12 following months:

  • Acute renal obstruction
  • Chronic renal obstruction
  • Chronic renal failure from BPH
  • Bladder stone
  • Recurrent urinary tract infection
  • Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
  • Hematuria from BPH

• Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)

• Patients previously not improved by an alpha1-blocker treatment

• Known hypersensitivity to alfuzosin

• History of postural hypotension or syncope

• Combination with other alpha1-blockers

• Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit

• Unstable angina pectoris

• Severe concomitant condition threatening life.

• Patients who had failed treatment with finasteride (Proscar)

• Patients with neuropathic bladder.

• Patients with history of previous surgery for BPH

• Patients with high risk for prostate cancer based on the clinical judgement of the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
improvements in urinary symptoms and quality of life index	During all the study conduct

Secondary Outcome Measures

Name	Time	Method
Improvement in sexual function	During all the study conduct
Improvement in maximum flow rate (determined by uroflowmetry)	During all the study conduct
Collection of spontaneously reported adverse events	At each visit

Trial Locations

Locations (1)

Sanofi-Aventis; 🇹🇭 Bangkok, Thailand