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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

July 16, 2009
March 29, 2010
September 2006
September 2008   (final data collection date for primary outcome measure)
Male Sexual Health Questionnaire Ejaculation score (MSHQ) [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941343 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Benign Prostatic Hyperplasia in Taiwan
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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Diseases
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
Experimental: 1
XATRAL 10mg OD
Intervention: Drug: Alfuzosin (XATRAL® - SL770499)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
September 2008
September 2008   (final data collection date for primary outcome measure)

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.

Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00941343
ALFUS_L_01816
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Sharon Chang Sanofi
Sanofi
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP