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
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   40 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941343

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00941343     History of Changes
Other Study ID Numbers: ALFUS_L_01816
Study First Received: July 16, 2009
Last Updated: March 29, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on September 16, 2014