A Beneficial Metabolic Effect of Daily Dosing of Tadalafil 5mg in Type 2 Diabetic Patients with Erectile Dysfunction; A randomized, double-blinded, placebo-controlled study
Not Applicable
Completed
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005666
- Lead Sponsor
- Myongji Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 90
Inclusion Criteria
1)75 aged 30-75 years male persons who had a regular sexual partner and had an intercourse once or more for the last one month
2)Type 2 diabetic men with ED
3)Newly diagnosed DM (HbA1c; 6.5~9%, or FBS > 126 )
4)No history of taking PDE5 inhibitors within the last 1 months
Exclusion Criteria
1)Contraindications for PDE5 inhibitors
2)Malignant tumors within the last 6 months
3)Prior or current use of thiazolidinediones, nitratest in any form (e.g., nitroglycerin, isosorbide dinitrate, nitroprusside, and others), alpha-blocking drugs (doxazosin, terazosin , or prazosin), protease inhibitors (ritonavir and others)
4)Change in dose of metformin within the last 3 months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method gycated hemoglobin A1c;glucose, insulin, c-peptide, insulin sensitivity (HOMA-IR) ß cell function (HOMA-ß), Body mass index, waist circumference, and lipid profile
- Secondary Outcome Measures
Name Time Method BUN, Creatinine, ALT, AST, Hemoglobin