Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

NCT ID: NCT00401661

Last Updated: 2009-09-15

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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Primary objective:

* 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.

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Alfuzosin for 24 weeks

Group Type EXPERIMENTAL

Alfuzosin

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from moderate to severe LUTS suggestive of BPH
* I-PSS total score ≥ 8
* Patients sexually active

Exclusion Criteria

* Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
* 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.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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Thailand

Other Identifiers

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ALFUS_L_01241

Identifier Type: -

Identifier Source: org_study_id

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