Status:
COMPLETED
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
Lead Sponsor:
Chesapeake Urology Research Associates
Collaborating Sponsors:
Sanofi
Conditions:
Erectile Dysfunction
Lower Urinary Tract Symptoms
Eligibility:
MALE
30-69 years
Phase:
PHASE3
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...
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 1:1 ratio to receive a placebo tablet once daily or Alfuz...
Eligibility Criteria
Inclusion
- Male, 30-69 years of age
- Has mild to moderate Erectile Dysfunction with a score \< 25 on EF domain in IIEF
- AUA score of less than or equal to 14
- Negative urinalysis with no evidence of a Urinary Tract Infection
Exclusion
- Blood pressure \< 90/50 or \> 170/110
- Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
- Diabetes Mellitus
- History of PSA \> 10
- History of confirmed or suspected prostate cancer
- History of Moderate/Severe Hepatic Insufficiency defined as \> 2X ULN
- On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
- Receive treatment with other investigational agents within 30 days prior to enrollment
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00893113
Start Date
June 1 2009
End Date
October 1 2012
Last Update
March 9 2018
Active Locations (4)
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1
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21204
2
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
3
Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States, 21061
4
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204