Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

Phase 4

Completed

• Conditions: BPH/LUTS/Sexual Functions

• Registration Number: NCT00542165
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2004-12
• Status Verified: 2007-10
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Last Update Submitted: 2007-10-10
• Last Update Posted: 2007-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
IIEF and GEQ (Global Efficacy Question)	at intermediate visit (M1) and at end-point visit(M3)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇰🇷 Seoul, Korea, Republic of