Benign Prostatic Hyperplasia in Taiwan

NCT00941343 | Completed

• 1 other identifier: ALFUS_L_01816
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Male Sexual Health Questionnaire Ejaculation score (MSHQ)

  At week 24

Secondary Outcomes (5)

• MSHQ Ejaculation score

  At week 14, 12 and 24

• International Prostate Symptom Score (I-PSS) including quality of life index

  At week 1, 4, 12 and 24

• Systolic and diastolic blood pressure

  At week 1, 4, 12 and 24

• Heart rate

  At week 1, 4, 12 and 24

• Prostate Specific Antigen

  At week 24

Study Arms (1)

1

EXPERIMENTAL

XATRAL 10mg OD

Drug: Alfuzosin (XATRAL® - SL770499)

Interventions

Alfuzosin (XATRAL® - SL770499) 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

1

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known history of hepatic or severe renal insufficiency
• unstable angina pectoris
• concomitant threatening-life condition
• Previous transurethral resection of the prostate (TURP)
• Planned prostate surgery or minimally invasive procedure during the whole study period
• Active urinary tract infection or acute prostatitis
• Neuropathic bladder
• Diagnosed prostate cancer
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Location

MeSH Terms

Conditions

Prostatic Diseases

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sharon Chang

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 30, 2010

Record last verified: 2010-03

Locations

TW (1)