SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Primary Objective:

• To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary Objective:

• To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,

• To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,

• To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),

• To assess the onset of action of XATRAL 10mg OD,

• To assess the peak flow rate improvement (Qmax),

• To assess the safety and the tolerability of XATRAL 10mg OD.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin

Criteria

Inclusion Criteria:

• Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),

• Patients with an I-PSS total score ≥ 8,

• Patients sexually active

Exclusion Criteria:

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life 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.

• Patients having received 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-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.