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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-12-31

Brief Summary

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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

Detailed Description

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Conditions

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BPH/LUTS/Sexual Functions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Alfuzosin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Tae-Young Ahn

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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L_8819

Identifier Type: -

Identifier Source: org_study_id