Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486785
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2007-06-14
Brief Title:
SAMBA Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily XATRAL OD 10mg Open 24-week Study
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None