Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

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

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Alfuzosin for 24 weeks

Primary Measures

• MSHQ Ejaculation score
  • Time Frame: End of treatment
    Safety Issue?: No

Secondary Measures

• MSHQ Ejaculation score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• MSHQ Ejaculation score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• Acute Urinary Retention
  • Time Frame: End of treatment
    Safety Issue?: No
• Correlation between MSHQ and IPSS
  • Time Frame: End of treatment
    Safety Issue?: No
• I-PSS total score
  • Time Frame: After 1 week of treatment
    Safety Issue?: No
• I-PSS total score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• I-PSS total score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• I-PSS total score
  • Time Frame: End of treatment
    Safety Issue?: No
• IPSS total score decrease = 3 points
  • Time Frame: End of treatment
    Safety Issue?: No
• IPSS: filling sub-score
  • Time Frame: After 1 week of treatment
    Safety Issue?: No
• IPSS: filling sub-score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• IPSS: filling sub-score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• IPSS: filling sub-score
  • Time Frame: End of treatment
    Safety Issue?: No
• IPSS: nocturia symptoms sub-score
  • Time Frame: After 1 week of treatment
    Safety Issue?: No
• IPSS: nocturia symptoms sub-score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• IPSS: nocturia symptoms sub-score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• IPSS: nocturia symptoms sub-score
  • Time Frame: End of treatment
    Safety Issue?: No
• IPSS: voiding sub-score
  • Time Frame: After 1 week of treatment
    Safety Issue?: No
• IPSS: voiding sub-score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• IPSS: voiding sub-score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• IPSS: voiding sub-score
  • Time Frame: End of treatment
    Safety Issue?: No
• MSHQ ejaculation: erection sub-score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• MSHQ ejaculation: erection sub-score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• MSHQ ejaculation: erection sub-score
  • Time Frame: End of treatment
    Safety Issue?: No
• MSHQ ejaculation: satisfaction sub-score
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• MSHQ ejaculation: satisfaction sub-score
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• MSHQ ejaculation: satisfaction sub-score
  • Time Frame: End of treatment
    Safety Issue?: No
• Quality of Life
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No
• Quality of Life
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• Quality of Life
  • Time Frame: End of treatment
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Natesumroeng Taweeporn Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00401661

Study ID Number: ALFUS_L_01241

ClinicalTrials.gov Identifier: NCT00401661

Health Authority: Thailand: Food and Drug Administration