Benign Prostatic Hyperplasia in Taiwan

Prostatic Diseases Clinical Trial

Official title:

Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941343
• Other study ID #: ALFUS_L_01816
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: March 29, 2010
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Diseases
• Prostatic Hyperplasia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Taiwan	Sanofi-Aventis Administrative Office	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Male Sexual Health Questionnaire Ejaculation score (MSHQ)		At week 24	No
Secondary	MSHQ Ejaculation score		At week 14, 12 and 24	No
Secondary	International Prostate Symptom Score (I-PSS) including quality of life index		At week 1, 4, 12 and 24	No
Secondary	Systolic and diastolic blood pressure		At week 1, 4, 12 and 24	No
Secondary	Heart rate		At week 1, 4, 12 and 24	No
Secondary	Prostate Specific Antigen		At week 24	No