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SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

NCT ID: NCT00486785

Last Updated: 2009-09-30

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

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-03-31

Brief Summary

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Primary Objective:

* To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary Objective:

* To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
* To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
* To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),
* To assess the onset of action of XATRAL 10mg OD,
* To assess the peak flow rate improvement (Qmax),
* To assess the safety and the tolerability of XATRAL 10mg OD.

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

Group Type EXPERIMENTAL

Alfuzosin

Intervention Type DRUG

Alfuzosin 10mg Once Daily for 24 weeks

Interventions

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Alfuzosin

Alfuzosin 10mg Once Daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
* Patients with an I-PSS total score ≥ 8,
* Patients sexually active

Exclusion Criteria

* Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life 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.
* Patients having received 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-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

Maximum Eligible Age

90 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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Jesus Ruiz, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bogotá, , Colombia

Site Status

Sanofi-Aventis

Quito, , Ecuador

Site Status

Sanofi-Aventis

Guatemala City, , Guatemala

Site Status

Sanofi-Aventis

México, , Mexico

Site Status

Countries

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Colombia Ecuador Guatemala Mexico

Other Identifiers

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ALFUS_L_01667

Identifier Type: -

Identifier Source: org_study_id