Phase 3
Completed N=74
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
Source: ClinicalTrials.gov NCT00893113 ↗Enrolled (actual)
74
Serious AEs
2.7%
Results posted
Aug 2016
Primary outcomePrimary: Change From Baseline Erectile Function Domain of the International Index of Erectile Function — 2.84; 2.84 Change in EF Domain Score from Baseline
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Erectile Function Domain of the International Index of Erectile Function |
2.84; 2.84 | — |
| SECONDARY Changes in American Urological Association (AUA) Symptom Index |
-.1333; .4222 | — |
| SECONDARY Change in Total International Index of Erectile Function (IIEF) Score |
4.644; 6.24 | — |
Eligibility Criteria
Inclusion Criteria
- Male, 30-69 years of age
- Has mild to moderate Erectile Dysfunction with a score 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
Data sourced from ClinicalTrials.gov (NCT00893113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.