Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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 hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.

Secondary objectives:

• MSHQ-EjD improvement by visit

• Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit

• Onset of action of XATRAL 10mg OD

• Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin

Criteria

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.