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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Tadalafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.5 mg/5 mg tadalafil<br>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). | Drug: Tadalafil<br>* Administered orally<br>* Other names: LY450190;|
| Experimental: 5 mg tadalafil<br>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). | Drug: Tadalafil<br>* Administered orally<br>* Other names: LY450190;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline through Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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? | Month 3, Month12, Month 24 |