BPH/LUTS/Sexual Functions Clinical Trial
Official title:
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
| Verified date | October 2007 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 166 |
| Est. completion date | December 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 50 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Sanofi-Aventis | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IIEF and GEQ (Global Efficacy Question) | at intermediate visit (M1) and at end-point visit(M3) | ||
| Secondary | blood pressure and heart rate measure in sitting position | at each visit | ||
| Secondary | IPSS and Quality of Life Score | at intermediate visit (M1) and at end-point visit(M3) | ||
| Secondary | Maximum flow rate and post voiding residual urine | at end-point visit(M3) | ||
| Secondary | Spontaneous reported adverse events | During all the study period |