Impotence Clinical Trial
Official title:
The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study
- To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and
without proven endothelial dysfunction and coexisting erectile concerns.
- To determine if chronic sildenafil use compared to placebo positively impacts
endothelial function among a cohort of diabetic mend with erectile dysfunction
- To assess the salvage rate of sildenafil - failures who demonstrate improved response
rates over time with chronic use
- To assess if microalbuminuria predicts flow-mediated dilation (FMD) response
- To measure and identify if other patient specific characteristics predict for sildenafil
erectile response and flow-mediated dilatation (FMD) response over time (patient
specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)
60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated
over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg)
will be a doubly blinded. Subjects will be followed by IIEF, diaries and brachial forearm
medial dilatation duplex scans, urinary microalbuminuria and serum chemistry.
Study time-points are at baseline, 6 and 12 weeks.
Study participants will be instructed to use the study medication at the specified frequency
but will be allowed flexibility to suit their erectile needs.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00159848 -
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
|
Phase 4 | |
| Completed |
NCT00654082 -
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT00882934 -
The Management of Erectile Dysfunction With Placebo Only
|
N/A | |
| Withdrawn |
NCT00382161 -
Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
|
Phase 3 | |
| Recruiting |
NCT00297544 -
Effect of Sildenafil on Endothelial Function
|
N/A | |
| Completed |
NCT00245596 -
Evaluation of the Index of Sexual Life Questionnaire
|
Phase 4 | |
| Completed |
NCT00249730 -
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
|
Phase 4 | |
| Completed |
NCT00547183 -
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
|
Phase 3 | |
| Completed |
NCT00422578 -
Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT00547092 -
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
|
Phase 4 | |
| Completed |
NCT00547508 -
To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking
|
Phase 3 | |
| Completed |
NCT00422734 -
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
|
Phase 3 | |
| Completed |
NCT00301262 -
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
|
Phase 4 | |
| Completed |
NCT00147628 -
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire
|
Phase 4 | |
| Completed |
NCT00245258 -
Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
|
Phase 4 | |
| Completed |
NCT00547287 -
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
|
Phase 3 | |
| Completed |
NCT03830164 -
Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT00498680 -
Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i
|
Phase 4 | |
| Completed |
NCT00150358 -
To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
|
Phase 4 | |
| Completed |
NCT00143221 -
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 4 |