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

Condition(s) targeted: BPH/LUTS/Sexual Functions

Intervention: Alfuzosin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Tae-Young Ahn, Study Director, Affiliation: Sanofi-Aventis

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

Official title: Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy

Study design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: IIEF and GEQ (Global Efficacy Question)

Secondary outcome:

blood pressure and heart rate measure in sitting position

IPSS and Quality of Life Score

Maximum flow rate and post voiding residual urine

Spontaneous reported adverse events

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

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.

Sanofi-Aventis, Seoul, Korea, Republic of

clinicalstudyresults.org

Starting date: March 2004
Ending date: December 2004
Last updated: October 10, 2007