Ignite Creation Date:
2024-05-05 @ 9:27 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00893113
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2009-04-08
Brief Title:
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
Sponsor:
Chesapeake Urology Research Associates
Organization:
Chesapeake Urology Research Associates
Study Overview
Official Title:
A Phase 3 Double Blind Placebo-Controlled Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS
Status:
COMPLETED
Status Verified Date:
2018-02
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:
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function EF domain of International Index of Erectile Function IIEF
Detailed Description:
This protocol is a placebo-controlled double-blind crossover trial Patients will be screened and then randomized to Group A or Group B at a 11 ratio to receive a placebo tablet once daily or Alfuzosin 10 mg daily for 12 weeks Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo At every visit the patients will complete an IIEF and an AUA symptom index
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