Andropause, Erectile Dysfunction
Conditions
Brief summary
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.
Interventions
DRUGTadalafil
Patients will be treated with Tadalafil for 8 weeks
Sponsors
Hanmi Pharmaceutical Company Limited
The Catholic University of Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Above 35 years men 2. Approving ADAM questionnaire and andropause patients with symptoms under contents ; easily fatigue, decreased sexual desire, general weakness, decreasing memory ect. 3. Patient with Erectile Dysfunction above 6 months 4. International Index of Erectile Function(IIEF-5) score under 21 5. Voluntarily one want to treatment with Tadalafil 5 mg daily 6. Voluntarily one agree this study and write informed consent
Exclusion criteria
1. Persons who have taken PDE-5 inhibitor within last one month for Erectile Dysfunction 2. Persons who taken testosterone treatment within last one month 3. Persons who be history of Myocardiac infarction 4. The history of taken organic nitrate drug 5. 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 6. Persons who have degrative retinal disease including Pigmentary retinites 7. Formerly persons who have one eye blindness by Artery anterior ischemic optic neuropathy with or without taking PDE5 inhibitor. 8. Persons who use inhibitor or agonist drug f Hepatic cytochrome P4503A4 9. Persons who use alpha antagonist add antihypertensive drug 10. Moderate liver or kidney failure 11. Major psychiatric or personality disorder 12. Persons have phobia trial drug 13. Persons have invasive treatment of prostate gland 14. Congenital anomaly of penis 15. Galactose, Lactose, Glucose intolerance patient 16. Research coordinators who are deemed unfit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on SF-12 Score from baseline to week 8 | week 0 to week 8 | The comparison of change of Quality of Live at baseline and 8 week (SF-12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on SF-12 Score from baseline to week 4 | week 0 to week 4 | The comparison of change of Quality of Life at baseline and 4 week (SF-12) |
| Change on bioimpedance Analysis from baseline to week 8 | week 0 to week 8 | The comparison of change of bioimpedance Analysis at baseline and 8 week |
| Change on IIEF-5 Score from baseline to week 4, week 8 | week 0 to week 4, week 8 | The comparison of score at baseline, 4 week and 8 week (IIEF-5) |
| Change on free radical from baseline to week 4, week 8 | week 0 to week 8 | — |
Countries
South Korea
Contacts
Primary ContactKeun-Sang Yum, M.D., PhD
Outcome results
None listed