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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00401661
Collaborator
(none)
110
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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.
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Alfuzosin for 24 weeks

Drug: Alfuzosin
One tablet of 10mg once daily at the end of evening meal

Outcome Measures

Primary Outcome Measures

  1. MSHQ Ejaculation score [End of treatment]

Secondary Outcome Measures

  1. MSHQ Ejaculation score [After 4 weeks of treatment]

  2. MSHQ Ejaculation score [After 12 weeks of treatment]

  3. Acute Urinary Retention [End of treatment]

  4. Correlation between MSHQ and IPSS [End of treatment]

  5. I-PSS total score [After 1 week of treatment]

  6. I-PSS total score [After 4 weeks of treatment]

  7. I-PSS total score [After 12 weeks of treatment]

  8. I-PSS total score [End of treatment]

  9. IPSS total score decrease = 3 points [End of treatment]

  10. IPSS: filling sub-score [After 1 week of treatment]

  11. IPSS: filling sub-score [After 4 weeks of treatment]

  12. IPSS: filling sub-score [After 12 weeks of treatment]

  13. IPSS: filling sub-score [End of treatment]

  14. IPSS: nocturia symptoms sub-score [After 1 week of treatment]

  15. IPSS: nocturia symptoms sub-score [After 4 weeks of treatment]

  16. IPSS: nocturia symptoms sub-score [After 12 weeks of treatment]

  17. IPSS: nocturia symptoms sub-score [End of treatment]

  18. IPSS: voiding sub-score [After 1 week of treatment]

  19. IPSS: voiding sub-score [After 4 weeks of treatment]

  20. IPSS: voiding sub-score [After 12 weeks of treatment]

  21. IPSS: voiding sub-score [End of treatment]

  22. MSHQ ejaculation: erection sub-score [After 4 weeks of treatment]

  23. MSHQ ejaculation: erection sub-score [After 12 weeks of treatment]

  24. MSHQ ejaculation: erection sub-score [End of treatment]

  25. MSHQ ejaculation: satisfaction sub-score [After 4 weeks of treatment]

  26. MSHQ ejaculation: satisfaction sub-score [After 12 weeks of treatment]

  27. MSHQ ejaculation: satisfaction sub-score [End of treatment]

  28. Quality of Life [After 4 weeks of treatment]

  29. Quality of Life [After 12 weeks of treatment]

  30. Quality of Life [End of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Sanofi-Aventis Bangkok Thailand

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Natesumroeng Taweeporn, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00401661
Other Study ID Numbers:
  • ALFUS_L_01241
First Posted:
Nov 20, 2006
Last Update Posted:
Sep 15, 2009
Last Verified:
Sep 1, 2009
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Alfuzosin

Study Results

No Results Posted as of Sep 15, 2009