Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hanmi Pharmaceutical Company Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil | Experimental | Patients will be treated with Tadalafil for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | Patients will be treated with Tadalafil for 8 weeks |
|
| 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 |
| 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 |
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keun-Sang Yum, M.D., PhD | Contact | 8231-820-3179 | yks6303@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Keun-Sang Yum, M.D., PhD | Uijeongbu St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uijeongbu St.Mary's Hospital | Recruiting | Gyeonggi-do | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
Not provided