Official Title: “Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), 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 Objective: - 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, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin
  • Alfuzosin 10mg Once Daily for 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.
  • Time Frame: 24 weeks
    Safety Issue?: No
• Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment)
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• - Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire
  • Time Frame: 24 weeks
    Safety Issue?: No
• - Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1)
  • Time Frame: 24 weeks
    Safety Issue?: No
• -Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life
  • Time Frame: 24 weeks
    Safety Issue?: No

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 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-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: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Jesus Ruiz, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486785

Study ID Number: ALFUS_L_01667

ClinicalTrials.gov Identifier: NCT00486785

Health Authority: Mexico: Ministry of Health