Overview

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

Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Alfuzosin
Criteria
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.