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

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00542165

Purpose

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

Condition	Intervention	Phase
BPH/LUTS/Sexual Functions	Drug: Alfuzosin	Phase IV

Drug Information available for: Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

IIEF and GEQ (Global Efficacy Question) [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]

Secondary Outcome Measures:

blood pressure and heart rate measure in sitting position [ Time Frame: at each visit ]
IPSS and Quality of Life Score [ Time Frame: at intermediate visit (M1) and at end-point visit(M3) ]
Maximum flow rate and post voiding residual urine [ Time Frame: at end-point visit(M3) ]
Spontaneous reported adverse events [ Time Frame: During all the study period ]

Enrollment:	166
Study Start Date:	March 2004
Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542165

Locations

Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Tae-Young Ahn

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Study ID Numbers:	L_8819
Study First Received:	October 9, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00542165
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hyperplasia
Hypertrophy
Alfuzosin

Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009