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

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

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.

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction; Andropause
• Intervention / Treatment: Drug: Tadalafil

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Keun-Sang Yum, M.D., PhD; Phone Number: 8231-820-3179; Email: yks6303@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Uijeongbu St.Mary's Hospital
    • Contact: Keun-Sang Yum, M.D., PhD; Phone Number: 82-31-820-3179; Email: yks6303@catholic.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tadalafil; Patients will be treated with Tadalafil for 8 weeks.	Drug: Tadalafil; Patients will be treated with Tadalafil for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change on free radical from baseline to week 4, week 8		week 0 to week 8

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Collaborators: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Keun-Sang Yum, M.D., PhD, Uijeongbu St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: TEDQOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided