Benign Prostatic Hyperplasia in Taiwan

Tracking Information
First Submitted Date ICMJE	July 16, 2009
First Posted Date ICMJE	July 17, 2009
Last Update Posted Date	March 30, 2010
Study Start Date ICMJE	September 2006
Actual Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 16, 2009)	Male Sexual Health Questionnaire Ejaculation score (MSHQ) [ Time Frame: At week 24 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00941343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 16, 2009)	MSHQ Ejaculation score [ Time Frame: At week 14, 12 and 24 ]; International Prostate Symptom Score (I-PSS) including quality of life index [ Time Frame: At week 1, 4, 12 and 24 ]; Systolic and diastolic blood pressure [ Time Frame: At week 1, 4, 12 and 24 ]; Heart rate [ Time Frame: At week 1, 4, 12 and 24 ]; Prostate Specific Antigen [ Time Frame: At week 24 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Benign Prostatic Hyperplasia in Taiwan
Official Title ICMJE	Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin
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
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostatic Diseases
Intervention ICMJE	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
Study Arms	Experimental: 1; XATRAL 10mg OD; Intervention: Drug: Alfuzosin (XATRAL® - SL770499)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 16, 2009)	362
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2008
Actual Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Taiwan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00941343
Other Study ID Numbers ICMJE	ALFUS_L_01816
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medical Affairs Study Director, sanofi-aventis
Study Sponsor ICMJE	Sanofi
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Sharon Chang Sanofi
PRS Account	Sanofi
Verification Date	March 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP