Benign Prostatic Hyperplasia in Taiwan

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00941343

First received: July 16, 2009

Last updated: March 29, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2009

Last Updated Date

March 29, 2010

Start Date ^ICMJE

September 2006

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Male Sexual Health Questionnaire Ejaculation score (MSHQ) [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

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

MSHQ Ejaculation score [ Time Frame: At week 14, 12 and 24 ] [ Designated as safety issue: No ]
International Prostate Symptom Score (I-PSS) including quality of life index [ Time Frame: At week 1, 4, 12 and 24 ] [ Designated as safety issue: No ]
Systolic and diastolic blood pressure [ Time Frame: At week 1, 4, 12 and 24 ] [ Designated as safety issue: No ]
Heart rate [ Time Frame: At week 1, 4, 12 and 24 ] [ Designated as safety issue: No ]
Prostate Specific Antigen [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

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 Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

362

Completion Date

September 2008

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.

Gender

Male

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00941343

Other Study ID Numbers ^ICMJE

ALFUS_L_01816

Has Data Monitoring Committee

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Sharon Chang

Sanofi

Information Provided By

Sanofi

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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