Clinical trial NCT02943356: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Erectile Dysfunction
Andropause
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2016-10-24
Enrollment: 40
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change on SF-12 Score from baseline to week 8
timeFrame: week 0 to week 8
Secondary outcomes:
measure: Change on SF-12 Score from baseline to week 4
timeFrame: week 0 to week 4
measure: Change on bioimpedance Analysis from baseline to week 8
timeFrame: week 0 to week 8
measure: Change on IIEF-5 Score from baseline to week 4, week 8
timeFrame: week 0 to week 4, week 8
measure: Change on free radical from baseline to week 4, week 8
timeFrame: week 0 to week 8
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Uijeongbu St.Mary's Hospital
Study officials:
affiliation: Uijeongbu St. Mary's Hospital
name: Keun-Sang Yum, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: