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OpenTrials
Completed

NCT Number: NCT00575913

Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

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).

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Key information

Conditions

Prostatic Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alfuzosin

Drug

Alfuzosin 10 mg One tablet per day after evening meal

Other names: (Xatral XL)

Primary outcomes

  1. improvements in urinary symptoms and quality of life index

    Time frame: During all the study conduct

Secondary outcomes

  1. Improvement in sexual function

    Time frame: During all the study conduct

  2. Improvement in maximum flow rate (determined by uroflowmetry)

    Time frame: During all the study conduct

  3. Collection of spontaneously reported adverse events

    Time frame: At each visit

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Acronym: ALEX-XL

Important dates

Study start
2003
Study completion
2005
First posted
Dec 18, 2007
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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