Status:
COMPLETED
Benign Prostatic Hyperplasia in Taiwan
Lead Sponsor:
Sanofi
Conditions:
Prostatic Diseases
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
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 sexu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00941343
Start Date
September 1 2006
End Date
September 1 2008
Last Update
March 30 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Taipei, Taiwan