NCT02943356

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 21, 2016

Last Update Submit

October 21, 2016

Conditions

Erectile DysfunctionAndropause

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change on SF-12 Score from baseline to week 4

    week 0 to week 4

  • Change on bioimpedance Analysis from baseline to week 8

    week 0 to week 8

  • Change on IIEF-5 Score from baseline to week 4, week 8

    week 0 to week 4, week 8

  • Change on free radical from baseline to week 4, week 8

    week 0 to week 8

Study Arms (1)

Tadalafil

EXPERIMENTAL

Patients will be treated with Tadalafil for 8 weeks.

Drug: Tadalafil

Interventions

TadalafilDRUG

Patients will be treated with Tadalafil for 8 weeks

Tadalafil

Eligibility Criteria

Age35 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uijeongbu St.Mary's Hospital

Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Keun-Sang Yum, M.D., PhD

    Uijeongbu St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keun-Sang Yum, M.D., PhD

CONTACT

8231-820-3179yks6303@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 24, 2016

Record last verified: 2016-10

Locations

KR(1)