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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

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.

Detailed Description

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Conditions

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Erectile Dysfunction Andropause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tadalafil

Patients will be treated with Tadalafil for 8 weeks.

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

Patients will be treated with Tadalafil for 8 weeks

Interventions

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Tadalafil

Patients will be treated with Tadalafil for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Keun-Sang Yum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Keun-Sang Yum, M.D., PhD

Role: CONTACT

8231-820-3179

Facility Contacts

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Keun-Sang Yum, M.D., PhD

Role: primary

82-31-820-3179

Other Identifiers

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TEDQOL

Identifier Type: -

Identifier Source: org_study_id

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