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

Primary Purpose

Erectile Dysfunction, Andropause

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tadalafil
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Erectile Dysfunction

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Uijeongbu St.Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tadalafil

Arm Description

Patients will be treated with Tadalafil for 8 weeks.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Change on bioimpedance Analysis from baseline 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
The comparison of score at baseline, 4 week and 8 week (IIEF-5)
Change on free radical from baseline to week 4, week 8

Full Information

First Posted
October 21, 2016
Last Updated
October 21, 2016
Sponsor
The Catholic University of Korea
Collaborators
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02943356
Brief Title
Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction
Official Title
Observational Study to Evaluate the Effect of Tadalafil 5mg Once Daily on Erectile Dysfunction and QOL in Andropause Patients With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Andropause

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tadalafil
Arm Type
Experimental
Arm Description
Patients will be treated with Tadalafil for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
Patients will be treated with Tadalafil for 8 weeks
Primary Outcome Measure Information:
Title
Change on SF-12 Score from baseline to week 8
Description
The comparison of change of Quality of Live at baseline and 8 week (SF-12)
Time Frame
week 0 to week 8
Secondary Outcome Measure Information:
Title
Change on SF-12 Score from baseline to week 4
Description
The comparison of change of Quality of Life at baseline and 4 week (SF-12)
Time Frame
week 0 to week 4
Title
Change on bioimpedance Analysis from baseline to week 8
Description
The comparison of change of bioimpedance Analysis at baseline and 8 week
Time Frame
week 0 to week 8
Title
Change on IIEF-5 Score from baseline to week 4, week 8
Description
The comparison of score at baseline, 4 week and 8 week (IIEF-5)
Time Frame
week 0 to week 4, week 8
Title
Change on free radical from baseline to week 4, week 8
Time Frame
week 0 to week 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keun-Sang Yum, M.D., PhD
Phone
8231-820-3179
Email
yks6303@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keun-Sang Yum, M.D., PhD
Organizational Affiliation
Uijeongbu St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uijeongbu St.Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun-Sang Yum, M.D., PhD
Phone
82-31-820-3179
Email
yks6303@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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