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Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin (SAMBA-Thailand)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00401661
First received: November 17, 2006
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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
Experimental: 1
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
Investigators
Study Director: Natesumroeng Taweeporn Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00401661     History of Changes
Other Study ID Numbers: ALFUS_L_01241
Study First Received: November 17, 2006
Last Updated: September 14, 2009
Health Authority: Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013