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Benign Prostatic Hyperplasia in Taiwan

Primary Purpose

Prostatic Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Alfuzosin (XATRAL® - SL770499)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Diseases

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

XATRAL 10mg OD

Outcomes

Primary Outcome Measures

Male Sexual Health Questionnaire Ejaculation score (MSHQ)

Secondary Outcome Measures

MSHQ Ejaculation score
International Prostate Symptom Score (I-PSS) including quality of life index
Systolic and diastolic blood pressure
Heart rate
Prostate Specific Antigen

Full Information

First Posted
July 16, 2009
Last Updated
March 29, 2010
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00941343
Brief Title
Benign Prostatic Hyperplasia in Taiwan
Official Title
Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
XATRAL 10mg OD
Intervention Type
Drug
Intervention Name(s)
Alfuzosin (XATRAL® - SL770499)
Intervention Description
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
Primary Outcome Measure Information:
Title
Male Sexual Health Questionnaire Ejaculation score (MSHQ)
Time Frame
At week 24
Secondary Outcome Measure Information:
Title
MSHQ Ejaculation score
Time Frame
At week 14, 12 and 24
Title
International Prostate Symptom Score (I-PSS) including quality of life index
Time Frame
At week 1, 4, 12 and 24
Title
Systolic and diastolic blood pressure
Time Frame
At week 1, 4, 12 and 24
Title
Heart rate
Time Frame
At week 1, 4, 12 and 24
Title
Prostate Specific Antigen
Time Frame
At week 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Chang
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Benign Prostatic Hyperplasia in Taiwan

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