Prostatic Diseases
Conditions
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
Interventions
DRUGAlfuzosin (XATRAL® - SL770499)
One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) * Sexually active * Sexual attempts at least once per month
Exclusion criteria
* Known history of hepatic or severe renal insufficiency * unstable angina pectoris * concomitant threatening-life condition * Previous transurethral resection of the prostate (TURP) * Had a minimally invasive procedure within 6 months prior to inclusion * Planned prostate surgery or minimally invasive procedure during the whole study period * Active urinary tract infection or acute prostatitis * Neuropathic bladder * Diagnosed prostate cancer * Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion * Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion * History of postural hypotension or syncope * Known hypersensitivity to alfuzosin * Patients illiterate or unable to understand or to complete the questionnaires * Patients having participated in any clinical study in the past month * Prostate Specific Antigen (PSA)\> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Male Sexual Health Questionnaire Ejaculation score (MSHQ) | At week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed