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Benign Prostatic Hyperplasia in Taiwan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941343
First Posted: July 17, 2009
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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

Condition Intervention
Prostatic Diseases Drug: Alfuzosin (XATRAL® - SL770499)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Male Sexual Health Questionnaire Ejaculation score (MSHQ) [ Time Frame: At week 24 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 362
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941343


Locations
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sharon Chang Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00941343     History of Changes
Other Study ID Numbers: ALFUS_L_01816
First Submitted: July 16, 2009
First Posted: July 17, 2009
Last Update Posted: March 30, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Prostatic Diseases
Pathologic Processes
Genital Diseases, Male
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents


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