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Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Diseases

Intervention: Alfuzosin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Paibulsirijit Sompob, Study Director, Affiliation: Sanofi


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).

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: improvements in urinary symptoms and quality of life index

Secondary outcome:

Improvement in sexual function

Improvement in maximum flow rate (determined by uroflowmetry)

Collection of spontaneously reported adverse events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


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.

Locations and Contacts

Sanofi-Aventis, Bangkok, Thailand
Additional Information

Starting date: September 2003
Last updated: April 8, 2008

Page last updated: August 23, 2015

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