Benign Prostatic Hyperplasia in Taiwan

March 29, 2010 updated by: Sanofi

Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
XATRAL 10mg OD
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Male Sexual Health Questionnaire Ejaculation score (MSHQ)
Time Frame: At week 24
At week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
MSHQ Ejaculation score
Time Frame: At week 14, 12 and 24
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
At week 1, 4, 12 and 24
Systolic and diastolic blood pressure
Time Frame: At week 1, 4, 12 and 24
At week 1, 4, 12 and 24
Heart rate
Time Frame: At week 1, 4, 12 and 24
At week 1, 4, 12 and 24
Prostate Specific Antigen
Time Frame: At week 24
At week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Sharon Chang, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 16, 2009

First Posted (Estimate)

July 17, 2009

Study Record Updates

Last Update Posted (Estimate)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFUS_L_01816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Diseases

Clinical Trials on Alfuzosin (XATRAL® - SL770499)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe