Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction
NCT ID: NCT02943356
Last Updated: 2016-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2016-07-31
2017-07-31
Brief Summary
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Patients will be observed for 8weeks.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Tadalafil
Patients will be treated with Tadalafil for 8 weeks.
Tadalafil
Patients will be treated with Tadalafil for 8 weeks
Interventions
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Tadalafil
Patients will be treated with Tadalafil for 8 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
35 Years
MALE
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
The Catholic University of Korea
OTHER
Responsible Party
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Keun-Sang Yum
Professor
Principal Investigators
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Keun-Sang Yum, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Uijeongbu St. Mary's Hospital
Locations
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Uijeongbu St.Mary's Hospital
Gyeonggi-do, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TEDQOL
Identifier Type: -
Identifier Source: org_study_id
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