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The objective of this study is to assess the safety and efficacy of oral YHD1023 5g or 10g on erectile dysfunction to investigate the optimal recommended dosage. Study period is 12 weeks including 4weeks of follow-up period without treatment. Study patients will fill in the international index of erectile function questionnaire and life satisfaction questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Active Comparator |
| |
| Group E | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHD1023 | Drug | 5g oral once daily |
| |
| YHD1023 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8 | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Improved patients from baseline in Question 3 & Question 4 of the International Index of Erectile Function(IIEF) at week 8 | *Improved: Score increased 1 or more compared to the baseline score Question 3: How many times were you able to insert your penis into your partner's vagina? Scores range from 0(did not have sexual intercourse) to 5(always or most times). Question 4: How many times did your erection last long enough for you to complete intercourse? Scores range from 0(did not have sexual intercourse) to 5(always or most times). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nam-Cheol Park, MD, PhD. | Busan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuhan Corporation | Seoul | 156-754 | South Korea |
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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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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
5g oral twice a day |
|
| YHD1023 | Drug | 10g oral once daily |
|
| Cialis | Drug | 5mg oral once daily |
|
| Placebo | Drug | Oral |
|
| Baseline, Week 8 |
| Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8 | Baseline, Week 8 |
| Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8 | *Improved: Response change from "No" at baseline to "Yes" at week 8 Question 2: Were you able to insert your penis into your partner's vagina? Question 3: Did your erection last long enough for you to complete intercourse with ejaculation? | Baseline, Week 8 |
| Percentage of Improved patients from baseline in Global Assessment Question(GAQ) at week 8 | *Improved: Yes response at week 8 GAQ: Did the 4 week treatment improve you ability to achieve and maintain your erection? | Week 8 |
| Mean change in Life Satisfaction score | Week 8 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |