Clinical trial NCT00893113: An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lower Urinary Tract Symptoms
Lead sponsor: Chesapeake Urology Research Associates
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2009-05-05
Enrollment: 74
Sex: MALE
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 1:1 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.

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

Primary outcomes:
measure: Change From Baseline Erectile Function Domain of the International Index of Erectile Function
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: Changes in American Urological Association (AUA) Symptom Index
timeFrame: Baseline and 12 Weeks
measure: Change in Total International Index of Erectile Function (IIEF) Score
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Glen Burnie
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
Study officials:
affiliation: Chesapeake Urology Research Associates
name: Ronald F Tutrone, MD
role: PRINCIPAL_INVESTIGATOR
References: