Status:
COMPLETED
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Lead Sponsor:
Sanofi
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
Primary objective: * End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients suffering from moderate to severe LUTS suggestive of BPH
- I-PSS total score ≥ 8
- Patients sexually active
- Exclusion criteria:
- Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
- Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
- Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
- Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
- Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
- History of postural hypotension or syncope
- Known hypersensitivity to alfuzosin
- 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 :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00401661
Start Date
June 1 2006
Last Update
September 15 2009
Active Locations (1)
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1
Sanofi-Aventis
Bangkok, Thailand