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Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin (SAMBA-Thailand)
This study has been completed.
First Received: November 17, 2006   Last Updated: September 14, 2009   History of Changes
Sponsor: 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: September 14, 2009
ClinicalTrials.gov Identifier: NCT00401661     History of Changes
Health Authority: Thailand: Food and Drug Administration

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 November 27, 2009



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