Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00401661

Purpose

Primary objective:

End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.

Secondary objectives:

MSHQ-EjD improvement by visit
Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
Onset of action of XATRAL 10mg OD
Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

Condition	Intervention	Phase
Prostatic Hyperplasia	Drug: Alfuzosin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-Week Study.

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

MSHQ Ejaculation score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MSHQ Ejaculation score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
MSHQ Ejaculation score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Acute Urinary Retention [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Correlation between MSHQ and IPSS [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
I-PSS total score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
I-PSS total score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
I-PSS total score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
I-PSS total score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
IPSS total score decrease = 3 points [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
IPSS: filling sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
IPSS: filling sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
IPSS: filling sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
IPSS: filling sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
IPSS: nocturia symptoms sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
IPSS: nocturia symptoms sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
IPSS: nocturia symptoms sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
IPSS: nocturia symptoms sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
IPSS: voiding sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
IPSS: voiding sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
IPSS: voiding sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
IPSS: voiding sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
MSHQ ejaculation: erection sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
MSHQ ejaculation: erection sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
MSHQ ejaculation: erection sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
MSHQ ejaculation: satisfaction sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
MSHQ ejaculation: satisfaction sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
MSHQ ejaculation: satisfaction sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	June 2006
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Alfuzosin for 24 weeks	Drug: Alfuzosin One tablet of 10mg once daily at the end of evening meal

Eligibility

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

Criteria

Inclusion criteria:

Patients suffering from moderate to severe LUTS suggestive of BPH
I-PSS total score ≥ 8
Patients sexually active

Exclusion criteria:

Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
History of postural hypotension or syncope
Known hypersensitivity to alfuzosin

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: NCT00401661

Locations

Thailand
Sanofi-aventis
Bangkok, Thailand

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Natesumroeng Taweeporn

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	ALFUS_L_01241
Study First Received:	November 17, 2006
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00401661 History of Changes
Health Authority:	Thailand: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Hyperplasia
Alfuzosin
Adrenergic Agents
Prostatic Diseases
Prostatic Hyperplasia

Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Genital Diseases, Male

Additional relevant MeSH terms:

Neurotransmitter Agents
Prostatic Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Genital Diseases, Male
Pharmacologic Actions
Hyperplasia
Pathologic Processes
Alfuzosin
Prostatic Hyperplasia
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on September 03, 2009