NCT00486785

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Alfuzosin	Alfuzosin 10mg Once Daily for 24 weeks

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2007-06-15
• Last updated: 2009-09-30

Locations

4 sites across 4 countries: Colombia, Ecuador, Guatemala, Mexico