Status:
COMPLETED
Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
Lead Sponsor:
Handok Inc.
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief 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 funct...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00427882
Start Date
September 1 2006
End Date
May 1 2007
Last Update
November 29 2007
Active Locations (1)
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1
Handok
Seoul, South Korea