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SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

NCT00486785 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2009-09-30

No results posted yet for this study

Summary

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.

Conditions

  • Prostatic Hyperplasia

Interventions

DRUG

Alfuzosin

Alfuzosin 10mg Once Daily for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Jesus Ruiz, MD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-10-31
Completion
2008-03-31

Countries

  • Colombia
  • Ecuador
  • Guatemala
  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486785 on ClinicalTrials.gov