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

Erectile Dysfunction Clinical Trial

Official title:

Observational Study to Evaluate the Effect of Tadalafil 5mg Once Daily on Erectile Dysfunction and QOL in Andropause Patients With Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02943356
• Other study ID #: TEDQOL
• Status: Recruiting
• Phase: Phase 4
• First received: October 21, 2016
• Last updated: October 21, 2016
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: The Catholic University of Korea
• Contact: Keun-Sang Yum, M.D., PhD
• Phone: 8231-820-3179
• Email: yks6303[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Andropause
• Erectile Dysfunction

Intervention

Drug:
• Tadalafil
Patients will be treated with Tadalafil for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Uijeongbu St.Mary's Hospital	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change on bioimpedance Analysis from baseline to week 8	The comparison of change of bioimpedance Analysis at baseline and 8 week	week 0 to week 8	No
Secondary	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	No
Secondary	Change on free radical from baseline to week 4, week 8		week 0 to week 8	No