Erectile Dysfunction Clinical Trial
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.
Verified date | February 2018 |
Source | Chesapeake Urology Research Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 74 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 69 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Chesapeake Urology Research Associates | Baltimore | Maryland |
United States | Chesapeake Urology Research Associates | Baltimore | Maryland |
United States | Chesapeake Urology Research Associates | Glen Burnie | Maryland |
United States | Chesapeake Urology Research Associates | Towson | Maryland |
Lead Sponsor | Collaborator |
---|---|
Chesapeake Urology Research Associates | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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