Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Alfuzosin

Criteria

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.