Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
Primary Purpose
BPH/LUTS/Sexual Functions
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
About this trial
This is an interventional treatment trial for BPH/LUTS/Sexual Functions
Eligibility Criteria
Inclusion Criteria:
- male patients suffering from LUTS lasting 6months and over
- male patients aged 50 years old and over who has a continuous active partner
Exclusion Criteria:
- Primary hypogonadism and neuropathy patients
- History of prostate surgery
- Patients with prostate cancer
- History of organ surgery or organ damage in pelvis
- History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
- Patients with haematuria caused by other reasons except BPH
- Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
- History of a malignant tumor within last 5 years
- Patients who are currently controlled with other medication for erectile dysfunction
- Patients who have been administered with androgen or antiandrogen
- Patients who is treated for psychiatric disorder or depression
- Combination with other alpha1-blockers
- Patients previously not improved by an alpha1-blocker treatment
- Known hypersensitivity to the alfuzosin
- History of postural hypotension or syncope
- Hepatic insufficiency
- Unstable angina pectoris
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
IIEF and GEQ (Global Efficacy Question)
Secondary Outcome Measures
blood pressure and heart rate measure in sitting position
IPSS and Quality of Life Score
Maximum flow rate and post voiding residual urine
Spontaneous reported adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542165
Brief Title
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
Official Title
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH/LUTS/Sexual Functions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Primary Outcome Measure Information:
Title
IIEF and GEQ (Global Efficacy Question)
Time Frame
at intermediate visit (M1) and at end-point visit(M3)
Secondary Outcome Measure Information:
Title
blood pressure and heart rate measure in sitting position
Time Frame
at each visit
Title
IPSS and Quality of Life Score
Time Frame
at intermediate visit (M1) and at end-point visit(M3)
Title
Maximum flow rate and post voiding residual urine
Time Frame
at end-point visit(M3)
Title
Spontaneous reported adverse events
Time Frame
During all the study period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male patients suffering from LUTS lasting 6months and over
male patients aged 50 years old and over who has a continuous active partner
Exclusion Criteria:
Primary hypogonadism and neuropathy patients
History of prostate surgery
Patients with prostate cancer
History of organ surgery or organ damage in pelvis
History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
Patients with haematuria caused by other reasons except BPH
Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
History of a malignant tumor within last 5 years
Patients who are currently controlled with other medication for erectile dysfunction
Patients who have been administered with androgen or antiandrogen
Patients who is treated for psychiatric disorder or depression
Combination with other alpha1-blockers
Patients previously not improved by an alpha1-blocker treatment
Known hypersensitivity to the alfuzosin
History of postural hypotension or syncope
Hepatic insufficiency
Unstable angina pectoris
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Young Ahn
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy
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