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

Phase 4

• Conditions: Erectile Dysfunction; Andropause
• Interventions: Drug: Tadalafil

• Registration Number: NCT02943356
• Lead Sponsor: The Catholic University of Korea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-10
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Last Update Submitted: 2016-10-21
• Study First Posted: 2016-10-24
• Last Update Posted: 2016-10-24
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tadalafil	Tadalafil	Patients will be treated with Tadalafil for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change on SF-12 Score from baseline to week 8	week 0 to week 8	The comparison of change of Quality of Live at baseline and 8 week (SF-12)

Secondary Outcome Measures

Name	Time	Method
Change on SF-12 Score from baseline to week 4	week 0 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	week 0 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	week 0 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	week 0 to week 8

Trial Locations

Locations (1)

Uijeongbu St.Mary's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of