Official Title: “An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia”

Primary:

To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.

Secondary: - To evaluate sexual function improvement - To evaluate LUTS (Lower Uninary Tract Symptoms) improvement - To evaluate the association between LUTS severity and sexual function. - To assess the safety and the tolerability of Alfuzosin 10mg OD.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: ALFUZOSIN

Primary Measures

• Mean change from baseline to the end of treatment in the MSHQ ejaculation total score

Secondary Measures

• Mean change from baseline to 4 weeks in MSHQ ejaculation total score
• Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score
• Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
• Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life
• Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
• Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
• Correlation between MSHQ and IPSS
• Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.

Inclusion Criteria:

• Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
• Patients with an I-PSS total score ≥ 8
• Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation

Exclusion Criteria:

• Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
• Patients who had a previous prostate surgery
• Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
• Patients with a prostate surgery or minimally invasive procedure during the whole study period
• Patients with an active urinary tract infection or prostatitis
• Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
• Patients with 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
• Patients with a history of postural hypotension or syncope
• Patients with a 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: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Handok Pharmaceuticals Co., Ltd.

Overall Clinical Trial Officials and Contacts

Hyou-Young Rhim, Dr. Study Director Handok Pharmaceuticals Co., Ltd.  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00427882

Study ID Number: ALFUS_L_01778

ClinicalTrials.gov Identifier: NCT00427882

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)