A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction
The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post-Marketing Surveillance of Bravonto in Korea|
- Number of participants with adverse events [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
- International Index of Erectile Function [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]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.
- Sexual Encounter Profile [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]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?".
- Global assessment Questionnaire [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]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"
- Number of participants with adverse events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Drug: No intervention
This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802359
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|