A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients 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 mirodenafil in participants with erectile dysfunction.

Detailed Description
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This is a non randomized (the study medication is not assigned by chance), open-label (all participants and study staff know the identity of the treatment), multi-center, prospective (looking forward using observations collected following participant enrollment), and non-comparative study in which participants with erectile dysfunction will be observed to evaluate the safety and effectiveness of mirodenafil for 12 weeks. Safety evaluations will include assessment of adverse events, and record of concomitant medications. The study will be conducted in Korea.

Official Title
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Post-Marketing Surveillance of Bravonto in Korea

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants diagnosed with erectile dysfunction Participants prescribed mirodenafil on demand Exclusion Criteria: - Participants who have administered mirodenafil for other than an approved indication

Ages Eligible for Study
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Minimum Age: 19 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mirodenafil<br> | Drug: No intervention<br>* This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function | The International Index of Erectile Function is used for the assessment of erectile dysfunction, with scores ranging from 0 to 30. Evaluation of points are as follows: 1-10 = severe erectile dysfunction, 11-16 = moderate dysfunction, 17-21 = mild to moderate dysfunction, 22-25 = mild dysfunction, 26-30 = no dysfunction. Lower scores indicate worsening. | Baseline (Week 0), Week 4, Week 8, and Week 12 | 
| Sexual Encounter Profile | The Sexual Encounter Profile is assessed after each sexual attempt consisting of a series of yes/no questions regarding specific aspects of each encounter. Question 1 asks, Were you able to insert your penis into your partner's vagina? and question 2 asks, Did your erection last long enough for you to complete intercourse with ejaculation?. | Baseline (Week 0), Week 4, Week 8, and Week 12 | 
| Global assessment Questionnaire | The Global Assessment Questionnaire is a self-administered questionnaire (Yes/No) that allows men to rate improvement in erectile function. Question 1 asks Has the treatment you have been taking over the past 4 weeks improved your erections? and if the answer is yes, question 2 then asks Has the treatment improved your ability to engage in sexual activity | Baseline (Week 0), Week 4, Week 8, and Week 12 | 
| Number of participants with adverse events |  | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Mirodenafil, Bravonto