Erectile DysfunctionPhase 4NCT02224846

A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

A Phase 4 study testing Tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant. Read more about this study

Who is it for?: Ages 22 to 69 years, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: Tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 635 participants
Where: 17 sitesChina
Study dates: Oct 2014to May 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 to 69 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a history of erectile dysfunction for at least 3 months.
Are sexually active and willing to remain sexually active with the same female partner during the study.
Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Who cannot join

Have erectile dysfunction, which is caused by any other primary sexual disorder.
Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
Have human immunodeficiency virus (HIV) infection.
Are using certain kinds of medicines, which are not allowed in this study.
Are allergic to tadalafil.

Show all 10Show fewer

Are planning to father a baby or are in a relationship with a pregnant partner.
Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
Have participated or discontinued from any other tadalafil clinical trial.
Have a history of drug, alcohol, or substance abuse within the past 6 months.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

China17 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, 100020
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Changchun, 130021
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Changsha, 410011
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chengdu, 610083
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Chongqing, 400037
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fuzhou, 350001
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guangzhou, 510180
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hangzhou, 310003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hefei, 230022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nanjing, 210008
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Qingdao, 266071
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shanghai, 200092
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Suzhou, 215004
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wenzhou, 325035
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wuhan, 430022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wuhan, 430030
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yinchuan, 750004

Other trials in China

About this study

Official title: Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction

Conditions: Erectile Dysfunction
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
Also called LY450190
Administered orally

Study groups in NCT02224846
Study group	Role	What they receive
2.5 mg/5 mg tadalafil	Experimental	2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). Receives: Drug: Tadalafil
5 mg tadalafil	Experimental	5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). Receives: Drug: Tadalafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through Month 12
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through Month 12

Secondary outcomes (6)

Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
Measured: Baseline, Month 1; Baseline, Month 3
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
Measured: Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
Measured: Month 1, Month 3
Percentage of Participants Achieving Normal Erectile Functioning
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.
Measured: Month 1, Month 3
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.
Measured: Month 6, Month 12, Month 18, Month 24
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.
GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?
Measured: Month 3, Month12, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014May 2017

First posted25 Aug 2014 (estimated)
Study startOct 2014
Primary completionMay 2016
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02224846
Sponsor's protocol ID: 15382
Other IDs: H6D-GH-B022
Status last verified: Sep 2019
First submitted: 20 Aug 2014
Last updated: 23 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction
ClinicalTrials.gov ID: NCT02224846
Acronym / sponsor ID: 15382
Conditions: Erectile Dysfunction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 635 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: May 2016 (actual)
Study completion: May 2017 (actual)
First posted: 25 Aug 2014 (estimated)
Results: Posted 27 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
2.5 mg/5 mg tadalafil	Experimental	Drug: Tadalafil2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
5 mg tadalafil	Experimental	Drug: Tadalafil5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).

Who may qualify

Ages: 22 to 69 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have a history of erectile dysfunction for at least 3 months.
Are sexually active and willing to remain sexually active with the same female partner during the study.
Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Key exclusion criteria (10 listed)

Have erectile dysfunction, which is caused by any other primary sexual disorder.
Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
Have human immunodeficiency virus (HIV) infection.
Are using certain kinds of medicines, which are not allowed in this study.

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
TadalafilAlso: LY450190Administered orally	Drug	2.5 mg/5 mg tadalafil, 5 mg tadalafil

Primary outcome

Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
Time frame: Baseline through Month 12
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
Time frame: Baseline through Month 12
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

6 secondary outcomes

Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
Time frame: Baseline, Month 1; Baseline, Month 3
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
Time frame: Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Time frame: Month 1, Month 3
Percentage of Participants Achieving Normal Erectile Functioning
Time frame: Month 1, Month 3
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Time frame: Month 6, Month 12, Month 18, Month 24
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Time frame: Month 3, Month12, Month 24

Results and safety

Results posted to the registry on 27 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2.5 mg/5 mg Tadalafil	211	192
5 mg Tadalafil	424	388

Primary outcome: Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)

Time frame: Baseline through Month 12. Number. Unit: Percentage of participants

Measure	2.5 mg/5 mg Tadalafil n = 210	5 mg Tadalafil n = 421
Value	33.8	35.9

Population analysed: All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.

Primary outcome: Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation

Time frame: Baseline through Month 12. Number. Unit: percentage of participants

Measure	2.5 mg/5 mg Tadalafil n = 210	5 mg Tadalafil n = 421
Value	1.4	0.7

Population analysed: All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2.5 mg/5 mg Tadalafil	15 of 210 (7.1%)	86 of 210 (41%)	Not reported
5 mg Tadalafil	17 of 421 (4%)	178 of 421 (42.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

17 sites 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, run by Eli Lilly and Company at 17 sites in China.

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. 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?

Yes. Results are posted in the registry (first posted 27 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) (time frame: Baseline through Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224846.

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 23 Sep 2019.