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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
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH/LUTS/Sexual Functions

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
October 9, 2007
Last Updated
October 10, 2007
Sponsor
Sanofi
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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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