drugset / Trial / NCT00401661

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

NCT00401661

Phase 4 Completed 110 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-06
Primary completion
2007-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Alfuzosin Small molecule 10 mg