BPH/LUTS/Sexual Functions
Conditions
Brief summary
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
Interventions
DRUGAlfuzosin
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male patients suffering from LUTS lasting 6months and over * male patients aged 50 years old and over who has a continuous active partner
Exclusion criteria
* Primary hypogonadism and neuropathy patients * History of prostate surgery * Patients with prostate cancer * History of organ surgery or organ damage in pelvis * History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months * Patients with haematuria caused by other reasons except BPH * Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents * History of a malignant tumor within last 5 years * Patients who are currently controlled with other medication for erectile dysfunction * Patients who have been administered with androgen or antiandrogen * Patients who is treated for psychiatric disorder or depression * Combination with other alpha1-blockers * Patients previously not improved by an alpha1-blocker treatment * Known hypersensitivity to the alfuzosin * History of postural hypotension or syncope * Hepatic insufficiency * Unstable angina pectoris 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 |
|---|---|
| IIEF and GEQ (Global Efficacy Question) | at intermediate visit (M1) and at end-point visit(M3) |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure and heart rate measure in sitting position | at each visit |
| IPSS and Quality of Life Score | at intermediate visit (M1) and at end-point visit(M3) |
| Maximum flow rate and post voiding residual urine | at end-point visit(M3) |
| Spontaneous reported adverse events | During all the study period |
Countries
South Korea
Outcome results
None listed