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Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
This study has been completed.
Study NCT00542165   Information provided by Sanofi-Aventis
First Received: October 9, 2007   Last Updated: October 10, 2007   History of Changes

October 9, 2007
October 10, 2007
March 2004
 
IIEF and GEQ (Global Efficacy Question) [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
Same as current
Complete list of historical versions of study NCT00542165 on ClinicalTrials.gov Archive Site
  • blood pressure and heart rate measure in sitting position [ Time Frame: at each visit ]
  • IPSS and Quality of Life Score [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
  • Maximum flow rate and post voiding residual urine [ Time Frame: at end-point visit(M3) ]
  • Spontaneous reported adverse events [ Time Frame: During all the study period ]
Same as current
 
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy

To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy

 
Phase IV
Interventional
Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
BPH/LUTS/Sexual Functions
Drug: Alfuzosin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
166
December 2004
 

Inclusion Criteria:

  • male patients suffering from LUTS lasting 6months and over
  • male patients aged 50 years old and over who has a continuous active partner

Exclusion Criteria:

  • Primary hypogonadism and neuropathy patients
  • History of prostate surgery
  • Patients with prostate cancer
  • History of organ surgery or organ damage in pelvis
  • History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
  • Patients with haematuria caused by other reasons except BPH
  • Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
  • History of a malignant tumor within last 5 years
  • Patients who are currently controlled with other medication for erectile dysfunction
  • Patients who have been administered with androgen or antiandrogen
  • Patients who is treated for psychiatric disorder or depression
  • Combination with other alpha1-blockers
  • Patients previously not improved by an alpha1-blocker treatment
  • Known hypersensitivity to the alfuzosin
  • History of postural hypotension or syncope
  • Hepatic insufficiency
  • Unstable angina pectoris

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00542165
 
L_8819
Sanofi-Aventis
 
Study Director: Tae-Young Ahn Sanofi-Aventis
Sanofi-Aventis
October 2007

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