Benign Prostatic Hyperplasia in Taiwan

NCT ID: NCT00941343

Last Updated: 2010-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

Brief Summary

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

Conditions

Prostatic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

XATRAL 10mg OD

Group Type: EXPERIMENTAL

Alfuzosin (XATRAL® - SL770499)

Intervention Type: DRUG

One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed

Interventions

Alfuzosin (XATRAL® - SL770499)

One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Sharon Chang

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

ALFUS_L_01816

Identifier Type: -

Identifier Source: org_study_id