drugset / Trial / NCT00486785

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

NCT00486785

Phase 4 Completed 431 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-04
Primary completion
2007-10
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Alfuzosin Small molecule 10 mg