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| ID | Type | Description | Link |
|---|---|---|---|
| MIRODENEDY4002 | Other Identifier | Janssen Korea, Ltd., Korea | |
| MIR-KOR-PMS | Other Identifier | Janssen Korea, Ltd., Korea |
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This prodect will be transferred to another company.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirodenafil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 4 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Participants who have administered mirodenafil for other than an approved indication
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Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| 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 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |