Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

October 10, 2007 updated by: Sanofi

Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IIEF and GEQ (Global Efficacy Question)
Time Frame: at intermediate visit (M1) and at end-point visit(M3)
at intermediate visit (M1) and at end-point visit(M3)

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure and heart rate measure in sitting position
Time Frame: at each visit
at each visit
IPSS and Quality of Life Score
Time Frame: at intermediate visit (M1) and at end-point visit(M3)
at intermediate visit (M1) and at end-point visit(M3)
Maximum flow rate and post voiding residual urine
Time Frame: at end-point visit(M3)
at end-point visit(M3)
Spontaneous reported adverse events
Time Frame: During all the study period
During all the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Tae-Young Ahn, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (ESTIMATE)

October 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2007

Last Update Submitted That Met QC Criteria

October 10, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8819

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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