Benign Prostatic Hyperplasia in Taiwan

Sanofi

Status: Completed

Conditions: Prostatic Diseases

Treatments: Drug: Alfuzosin (XATRAL® - SL770499)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941343

ALFUS_L_01816

Details and patient eligibility

About

Primary Objective:

• To assess the sexual function of Benign Prostatic Hyperplasia patients

Secondary Objective:

• To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
• To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
• To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
• To assess the onset of action of XATRAL 10mg OD
• To assess the peak urinary flow rate
• To assess the safety and the tolerability of XATRAL 10mg OD

Enrollment: 362 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)
• Sexually active
• Sexual attempts at least once per month

Exclusion criteria

• Known history of hepatic or severe renal insufficiency
• unstable angina pectoris
• concomitant threatening-life condition
• Previous transurethral resection of the prostate (TURP)
• Had a minimally invasive procedure within 6 months prior to inclusion
• Planned prostate surgery or minimally invasive procedure during the whole study period
• Active urinary tract infection or acute prostatitis
• Neuropathic bladder
• Diagnosed prostate cancer
• Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion
• Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion
• History of postural hypotension or syncope
• Known hypersensitivity to alfuzosin
• Patients illiterate or unable to understand or to complete the questionnaires
• Patients having participated in any clinical study in the past month
• Prostate Specific Antigen (PSA)> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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362 participants in 1 patient group

1

Experimental group

Description:

XATRAL 10mg OD

Treatment:

Drug: Alfuzosin (XATRAL® - SL770499)