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An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

CompletedPhase 3

Sponsor: Chesapeake Urology Research Associates

Conditions: Erectile Dysfunction, Lower Urinary Tract Symptoms

Interventions: Placebo, Alfuzosin

Countries: United States

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).

Eligibility overview

Sex: MALE

Age: 30 Years to 69 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (4)

Baltimore, Maryland, United States
Baltimore, Maryland, United States
Glen Burnie, Maryland, United States
Towson, Maryland, United States