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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014