Erectile DysfunctionPhase 4NCT02943356
Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction
A Phase 4 study testing Tadalafil in people with Erectile Dysfunction and Andropause, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Andropause
- What is being tested?
- Tadalafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Major psychiatric or personality disorder
- Persons have phobia trial drug
- Persons have invasive treatment of prostate gland
- Congenital anomaly of penis
- Galactose, Lactose, Glucose intolerance patient
- Research coordinators who are deemed unfit
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Uijeongbu St.Mary's Hospital
Gyeonggi-do
Keun-Sang Yum, M.D., PhD, 82-31-820-3179, yks6303@catholic.ac.kr
About this study
Official title: 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.
- Conditions
- Erectile Dysfunction, Andropause
- Being tested
- Tadalafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Patients will be treated with Tadalafil for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Patients will be treated with Tadalafil for 8 weeks. Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: week 0 to week 8
Secondary outcomes (4)
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)
Measured: 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
Measured: 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)
Measured: week 0 to week 4, week 8
Change on free radical from baseline to week 4, week 8
Measured: week 0 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Responsible party
- Principal investigator, Keun-Sang Yum, The Catholic University of Korea
- Investigators
- Keun-Sang Yum, M.D., PhD, Principal investigator, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943356
- Sponsor's protocol ID
- TEDQOL
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Effect of Tadalafil 5mg Once Daily on Erectile Dysfunction and QOL in Andropause Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02943356
- Acronym / sponsor ID
- TEDQOL
- Conditions
- Erectile Dysfunction, Andropause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: TadalafilPatients will be treated with Tadalafil for 8 weeks. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TadalafilPatients will be treated with Tadalafil for 8 weeks | Drug | Tadalafil |
Primary outcome
Change on SF-12 Score from baseline to week 8
Time frame: week 0 to week 8
The comparison of change of Quality of Live at baseline and 8 week (SF-12)
4 secondary outcomes
Change on SF-12 Score from baseline to week 4
Time frame: week 0 to week 4
Change on bioimpedance Analysis from baseline to week 8
Time frame: week 0 to week 8
Change on IIEF-5 Score from baseline to week 4, week 8
Time frame: week 0 to week 4, week 8
Change on free radical from baseline to week 4, week 8
Time frame: week 0 to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keun-Sang Yum, M.D., PhD principal investigator
Uijeongbu St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil in people with Erectile Dysfunction and Andropause, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keun-Sang Yum, M.D., PhD (8231-820-3179, yks6303@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on SF-12 Score from baseline to week 8 (time frame: week 0 to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.