Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction

Study Overview
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Brief Summary
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Observational study to evaluate the effect of Tadalafil 5mg once daily on Erectile Dysfunction and QOL in Andropause patients with Erectile Dysfunction. Patients will be observed for 8weeks.

Official Title
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Observational Study to Evaluate the Effect of Tadalafil 5mg Once Daily on Erectile Dysfunction and QOL in Andropause Patients With Erectile Dysfunction

Conditions
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Erectile Dysfunction, Andropause

Intervention / Treatment
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* Drug: Tadalafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 35 years men Approving ADAM questionnaire and andropause patients with symptoms under contents ; easily fatigue, decreased sexual desire, general weakness, decreasing memory ect. Patient with Erectile Dysfunction above 6 months International Index of Erectile Function(IIEF-5) score under 21 Voluntarily one want to treatment with Tadalafil 5 mg daily Voluntarily one agree this study and write informed consent Exclusion Criteria: Persons who have taken PDE-5 inhibitor within last one month for Erectile Dysfunction Persons who taken testosterone treatment within last one month Persons who be history of Myocardiac infarction The history of taken organic nitrate drug The history of cardiovascular disease In myocardial infarction within the last 90 days was now Unstable angina or angina pectoris during intercourse that occurred New York Heart Association Class 2 during the last six months or more sever cardiac failure Uncontrolled arrythmia, hypotension(<90/50mmHg), or uncontrolled blood pressure(>170/100mmHg) Persons who have a stroke within the last six months Persons who have degrative retinal disease including Pigmentary retinites Formerly persons who have one eye blindness by Artery anterior ischemic optic neuropathy with or without taking PDE5 inhibitor. Persons who use inhibitor or agonist drug f Hepatic cytochrome P4503A4 Persons who use alpha antagonist add antihypertensive drug Moderate liver or kidney failure Major psychiatric or personality disorder Persons have phobia trial drug Persons have invasive treatment of prostate gland Congenital anomaly of penis Galactose, Lactose, Glucose intolerance patient Research coordinators who are deemed unfit

Ages Eligible for Study
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Minimum Age: 35 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil<br>Patients will be treated with Tadalafil for 8 weeks. | Drug: Tadalafil<br>* Patients will be treated with Tadalafil for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on SF-12 Score from baseline to week 8 | The comparison of change of Quality of Live at baseline and 8 week (SF-12) | week 0 to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on SF-12 Score from baseline to week 4 | The comparison of change of Quality of Life at baseline and 4 week (SF-12) | week 0 to week 4 | 
| Change on bioimpedance Analysis from baseline to week 8 | The comparison of change of bioimpedance Analysis at baseline and 8 week | week 0 to week 8 | 
| Change on IIEF-5 Score from baseline to week 4, week 8 | The comparison of score at baseline, 4 week and 8 week (IIEF-5) | week 0 to week 4, week 8 | 
| Change on free radical from baseline to week 4, week 8 |  | week 0 to week 8 |