NCT00401661

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Alfuzosin	One tablet of 10mg once daily at the end of evening meal

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• First posted: 2006-11-20
• Last updated: 2009-09-15

Locations

1 site across 1 country: Thailand