Overview

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Sanofi
Treatments:
Alfuzosin