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

Primary objective: - To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary objectives: - To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders, - To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions, - To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-item version of the International Index of Erectile Function), - To assess the onset of action of XATRAL 10mg OD, - To assess the peak flow rate improvement (Qmax) - To assess the safety and the tolerability of XATRAL 10mg OD.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin
  • Once daily at end of evening meals for 24 weeks

Primary Measures

• Mean change in the MSHQ Ejaculation score (sum of questions Q5 to Q12).
  • Time Frame: Baseline to end of treatment
    Safety Issue?: No

Secondary Measures

• Mean change in MSHQ Ejaculation score
  • Time Frame: Baseline to 4 and 12 weeks of treatment
    Safety Issue?: No
• Mean change from baseline in MSHQ ejaculation questions (Q5 to Q12), in the erection and satisfaction sub-scores, in the IIEF-5 total score
  • Time Frame: 4, 12 and 24 weeks of treatment
    Safety Issue?: No
• Correlation between MSHQ and IIEF-5
  • Time Frame: Baseline to end of study
    Safety Issue?: No
• Mean change from baseline in I-PSS (International Prostate Score Symptom) total score and sub-scores (objective onset of action)
  • Time Frame: week 1
    Safety Issue?: No
• Onset of action based on patient perception
  • Time Frame: week 4
    Safety Issue?: No
• Mean change from baseline in the I-PSS total score and in the Quality of Life (8th question of I-PSS), in IPSS sub-scores for voiding, filling and nocturia symptoms
  • Time Frame: 4, 12 and 24 weeks of treatment
    Safety Issue?: No
• Percentage of patients with a IPSS total score decrease ≥ 3 points
  • Time Frame: baseline to end of study
    Safety Issue?: No
• Percentage of patients with a IPSS total score increase ≥ 4 points
  • Time Frame: baseline to end of study
    Safety Issue?: No
• Percentage of patients with Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH) surgery
  • Time Frame: Baseline to end of study
    Safety Issue?: No
• Risk factors for AUR or BPH surgery
  • Time Frame: baseline to end of study
    Safety Issue?: No
• Correlation between MSHQ and IPSS
  • Time Frame: baseline to end of study
    Safety Issue?: No
• Comparison of mean change in sexual function, urinary symptoms and Quality of Life among the different regions
  • Time Frame: From baseline to end of study
    Safety Issue?: No
• Mean change from baseline of treatment in the peak urinary flow rate (Qmax)
  • Time Frame: 1, 4, 12 and 24 weeks
    Safety Issue?: No
• Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA and creatinine.
  • Time Frame: Throughout the study
    Safety Issue?: Yes

Inclusion criteria:

• Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
• Patients with an I-PSS total score ≥ 8,
• Patients sexually active.

Exclusion criteria:

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life 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
• Patients having received 5a-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or a1-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 Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Natesumroeng Taweeporn Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 28, 2008

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