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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00486785
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 4
Start date April 2006
Completion date March 2008

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