The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.
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.
Study Type
OBSERVATIONAL
Enrollment
379
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.
Number of participants with adverse events
Time frame: Up to 4 weeks
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.
Time frame: 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?".
Time frame: 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"
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Number of participants with adverse events
Time frame: Up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.