Skip to main content
OpenTrials
Completed

NCT Number: NCT00401661

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alfuzosin

Drug

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

Primary outcomes

  1. MSHQ Ejaculation score

    Time frame: End of treatment

Secondary outcomes

  1. MSHQ Ejaculation score

    Time frame: After 4 weeks of treatment

  2. MSHQ Ejaculation score

    Time frame: After 12 weeks of treatment

  3. Acute Urinary Retention

    Time frame: End of treatment

  4. Correlation between MSHQ and IPSS

    Time frame: End of treatment

  5. I-PSS total score

    Time frame: After 1 week of treatment

  6. I-PSS total score

    Time frame: After 4 weeks of treatment

  7. I-PSS total score

    Time frame: After 12 weeks of treatment

  8. I-PSS total score

    Time frame: End of treatment

  9. IPSS total score decrease = 3 points

    Time frame: End of treatment

  10. IPSS: filling sub-score

    Time frame: After 1 week of treatment

  11. IPSS: filling sub-score

    Time frame: After 4 weeks of treatment

  12. IPSS: filling sub-score

    Time frame: After 12 weeks of treatment

  13. IPSS: filling sub-score

    Time frame: End of treatment

  14. IPSS: nocturia symptoms sub-score

    Time frame: After 1 week of treatment

  15. IPSS: nocturia symptoms sub-score

    Time frame: After 4 weeks of treatment

  16. IPSS: nocturia symptoms sub-score

    Time frame: After 12 weeks of treatment

  17. IPSS: nocturia symptoms sub-score

    Time frame: End of treatment

  18. IPSS: voiding sub-score

    Time frame: After 1 week of treatment

  19. IPSS: voiding sub-score

    Time frame: After 4 weeks of treatment

  20. IPSS: voiding sub-score

    Time frame: After 12 weeks of treatment

  21. IPSS: voiding sub-score

    Time frame: End of treatment

  22. MSHQ ejaculation: erection sub-score

    Time frame: After 4 weeks of treatment

  23. MSHQ ejaculation: erection sub-score

    Time frame: After 12 weeks of treatment

  24. MSHQ ejaculation: erection sub-score

    Time frame: End of treatment

  25. MSHQ ejaculation: satisfaction sub-score

    Time frame: After 4 weeks of treatment

  26. MSHQ ejaculation: satisfaction sub-score

    Time frame: After 12 weeks of treatment

  27. MSHQ ejaculation: satisfaction sub-score

    Time frame: End of treatment

  28. Quality of Life

    Time frame: After 4 weeks of treatment

  29. Quality of Life

    Time frame: After 12 weeks of treatment

  30. Quality of Life

    Time frame: End of treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.

Acronym: SAMBA-Thailand

Important dates

Study start
2006
Primary completion
2007
First posted
Nov 20, 2006
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.