A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction
|ClinicalTrials.gov Identifier: NCT01802359|
Recruitment Status : Terminated (This prodect will be transferred to another company.)
First Posted : March 1, 2013
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment|
|Erectile Dysfunction||Drug: No intervention|
|Study Type :||Observational|
|Actual Enrollment :||379 participants|
|Official Title:||Post-Marketing Surveillance of Bravonto in Korea|
|Actual Study Start Date :||November 7, 2011|
|Actual Primary Completion Date :||May 31, 2012|
|Actual Study Completion Date :||May 31, 2012|
Drug: No intervention
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 [ Time Frame: Baseline (Week 0), Week 4, Week 8, and Week 12 ]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 ]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 ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802359
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|