Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
NCT ID: NCT00401661
Last Updated: 2009-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
110 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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* End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.
Secondary objectives:
* MSHQ-EjD improvement by visit
* Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
* Onset of action of XATRAL 10mg OD
* Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Alfuzosin for 24 weeks
Alfuzosin
One tablet of 10mg once daily at the end of evening meal
Interventions
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Alfuzosin
One tablet of 10mg once daily at the end of evening meal
Eligibility Criteria
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Inclusion Criteria
* I-PSS total score ≥ 8
* Patients sexually active
Exclusion Criteria
* 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
* Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-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.
50 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Natesumroeng Taweeporn
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Bangkok, , Thailand
Countries
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Other Identifiers
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ALFUS_L_01241
Identifier Type: -
Identifier Source: org_study_id
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