Benign Prostatic Hyperplasia in Taiwan
Not Applicable
Completed
- Conditions
- Prostatic Diseases
- Interventions
- Registration Number
- NCT00941343
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To assess the sexual function of Benign Prostatic Hyperplasia patients
Secondary Objective:
* To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
* To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
* To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
* To assess the onset of action of XATRAL 10mg OD
* To assess the peak urinary flow rate
* To assess the safety and the tolerability of XATRAL 10mg OD
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 362
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Alfuzosin (XATRAL® - SL770499) XATRAL 10mg OD
- Primary Outcome Measures
Name Time Method Male Sexual Health Questionnaire Ejaculation score (MSHQ) At week 24
- Secondary Outcome Measures
Name Time Method MSHQ Ejaculation score At week 14, 12 and 24 International Prostate Symptom Score (I-PSS) including quality of life index At week 1, 4, 12 and 24 Systolic and diastolic blood pressure At week 1, 4, 12 and 24 Heart rate At week 1, 4, 12 and 24 Prostate Specific Antigen At week 24
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇳Taipei, Taiwan