Trial · NCT02224846
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
NCT02224846, Phase 4, Completed, Eli Lilly and Company; results first posted 2017-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction. Trials, record NCT02224846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
- NCT number
- NCT02224846
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 635 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction
- Interventions
- Tadalafil
- First posted
- 2014-08-25
- Last updated
- 2019-09-23
- Results first posted
- 2017-10-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | 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. |
| Primary | Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | 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. |
| Secondary | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Baseline, Month 1; Baseline, Month 3 | 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. |
| Secondary | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24 | 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. |
| Secondary | Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary | Month 1, Month 3 | 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. |
| Secondary | Percentage of Participants Achieving Normal Erectile Functioning | Month 1, Month 3 | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 1 and Month 3. |
| Secondary | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 6, Month 12, Month 18, Month 24 | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 6 and Month 12. |
| Secondary | Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3, Month12, Month 24 | 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? |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | Baseline through Month 12 | All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | Baseline through Month 12 | All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Baseline, Month 1; Baseline, Month 3 | All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24 | All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Month 1, Month 3 | All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Percentage of participants | MEAN |
| SECONDARY | Percentage of Participants Achieving Normal Erectile Functioning | Month 1, Month 3 | All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Percentage of partcipants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 6, Month 12, Month 18, Month 24 | All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3, Month12, Month 24 | All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | 2.5 mg/5 mg Tadalafil | 33.8 | Percentage of participants | ||
| Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | 5 mg Tadalafil | 35.9 | Percentage of participants | ||
| Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | 2.5 mg/5 mg Tadalafil | 1.4 | percentage of participants | ||
| Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | 5 mg Tadalafil | 0.7 | percentage of participants | ||
| Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | 2.5 mg/5 mg Tadalafil | Month 1 | 4.5 | Standard Error 0.42 | units on a scale |
| Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | 5 mg Tadalafil | Month 1 | 6.2 | Standard Error 0.28 | units on a scale |
| Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | 2.5 mg/5 mg Tadalafil | Month 3 | 6.1 | Standard Error 0.44 | units on a scale |
| Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | 5 mg Tadalafil | Month 3 | 7.4 | Standard Error 0.28 | units on a scale |
| Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | 2.5 mg/5 mg Tadalafil | Month 6 | 8.2 | Standard Error 0.38 | units on a scale |
| Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | 5 mg Tadalafil | Month 6 | 7.9 | Standard Error 0.27 | units on a scale |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Month 3) | STARTED | 2.5 mg/5 mg Tadalafil | 211 | |
| Period 1 (Month 3) | STARTED | 5 mg Tadalafil | 424 | |
| Period 1 (Month 3) | Received at Least One Dose of Study Drug | 2.5 mg/5 mg Tadalafil | 210 | |
| Period 1 (Month 3) | Received at Least One Dose of Study Drug | 5 mg Tadalafil | 421 | |
| Period 1 (Month 3) | COMPLETED | 2.5 mg/5 mg Tadalafil | 192 | |
| Period 1 (Month 3) | COMPLETED | 5 mg Tadalafil | 388 | |
| Period 1 (Month 3) | NOT COMPLETED | 2.5 mg/5 mg Tadalafil | 19 | |
| Period 1 (Month 3) | NOT COMPLETED | 5 mg Tadalafil | 36 | |
| Period 2 (Month 3 to Month 12) | STARTED | 2.5 mg/5 mg Tadalafil | 192 | |
| Period 2 (Month 3 to Month 12) | STARTED | 5 mg Tadalafil | 388 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events526
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 2.5 mg/5 mg Tadalafil | 1 | 210 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 5 mg Tadalafil | 1 | 421 | 1 |
| other | Angina unstable | Cardiac disorders | 2.5 mg/5 mg Tadalafil | 0 | 210 | 0 |
| other | Angina unstable | Cardiac disorders | 5 mg Tadalafil | 1 | 421 | 1 |
| other | Arrhythmia | Cardiac disorders | 2.5 mg/5 mg Tadalafil | 1 | 210 | 1 |
| other | Arrhythmia | Cardiac disorders | 5 mg Tadalafil | 0 | 421 | 0 |
| other | Arteriosclerosis coronary artery | Cardiac disorders | 2.5 mg/5 mg Tadalafil | 1 | 210 | 1 |
| other | Arteriosclerosis coronary artery | Cardiac disorders | 5 mg Tadalafil | 0 | 421 | 0 |
| other | Atrial fibrillation | Cardiac disorders | 2.5 mg/5 mg Tadalafil | 1 | 210 | 1 |
| other | Atrial fibrillation | Cardiac disorders | 5 mg Tadalafil | 1 | 421 | 1 |
1 to 10 of 526Source ClinicalTrials.gov
See all 526 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2.5 mg/5 mg Tadalafil | ||
| Total, all-cause mortality | 5 mg Tadalafil | ||
| Total, other adverse events | 2.5 mg/5 mg Tadalafil | 86 | 210 |
| Total, other adverse events | 5 mg Tadalafil | 178 | 421 |
| Total, serious adverse events | 2.5 mg/5 mg Tadalafil | 15 | 210 |
| Total, serious adverse events | 5 mg Tadalafil | 17 | 421 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 2.5 mg/5 mg Tadalafil vs 5 mg Tadalafil: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02224846
GET https://conductscience.org/api/trials/v1/NCT02224846/results?page=2