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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
  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:

U.S. FDA Resources

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
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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013