Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

Sanofi

Status and phase

Completed

Phase 4

Conditions

BPH/LUTS/Sexual Functions

Treatments

Drug: Alfuzosin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00542165

L_8819

Details and patient eligibility

About

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

Enrollment

166 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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