Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
- Registration Number
- NCT00401661
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Alfuzosin Alfuzosin for 24 weeks
- Primary Outcome Measures
Name Time Method MSHQ Ejaculation score End of treatment
- Secondary Outcome Measures
Name Time Method MSHQ Ejaculation score After 12 weeks of treatment Acute Urinary Retention End of treatment Correlation between MSHQ and IPSS End of treatment I-PSS total score End of treatment IPSS total score decrease = 3 points End of treatment IPSS: filling sub-score End of treatment IPSS: nocturia symptoms sub-score End of treatment IPSS: voiding sub-score End of treatment MSHQ ejaculation: erection sub-score End of treatment MSHQ ejaculation: satisfaction sub-score End of treatment Quality of Life End of treatment
Trial Locations
- Locations (1)
Sanofi-Aventis
🇹🇭Bangkok, Thailand