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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.

Conditions
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Erectile Dysfunction, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: Placebo
* Drug: Alfuzosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo, Then Alfuzosin<br>Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. | Drug: Placebo<br>* Alfuzosin-matched One tablet once daily<br>Drug: Alfuzosin<br>* 10 mg once daily<br>|
| Experimental: Alfuzosin, Then Placebo<br>Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks. | Drug: Placebo<br>* Alfuzosin-matched One tablet once daily<br>Drug: Alfuzosin<br>* 10 mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Erectile Function Domain of the International Index of Erectile Function | The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction. | Baseline and 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in American Urological Association (AUA) Symptom Index | The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35). | Baseline and 12 Weeks | 
| Change in Total International Index of Erectile Function (IIEF) Score | The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction). | Baseline and 12 Weeks |