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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00575913
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Diseases	Drug: Alfuzosin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
• Study Start Date: Sep 1, 2003
• Actual Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. improvements in urinary symptoms and quality of life index [During all the study conduct]

Secondary Outcome Measures

1. Improvement in sexual function [During all the study conduct]

2. Improvement in maximum flow rate (determined by uroflowmetry) [During all the study conduct]

3. Collection of spontaneously reported adverse events [At each visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Bangkok		Thailand

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Paibulsirijit Sompob, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00575913
• Other Study ID Numbers: L_8935
• First Posted: Dec 18, 2007
• Last Update Posted: Apr 10, 2008
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: Prostatic Diseases; Lower Urinary Tract Symptoms; Alfuzosin

Study Results

No Results Posted as of Apr 10, 2008