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The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avanafil 100mg | Experimental |
| |
| Avanafil 200mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avanafil | Drug | 2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of EF domain score in the IIEF(The International Index of Erectile Function) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of successful rate in SEPQ2,Q3,Q4,Q5 Change of score in other domains of IIEF Change of IIEF Q3 and Q4 score GEAQ The rate of normal erectile function | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Kwan Park, PhD | Chonbuk National University Hospital | Principal Investigator |
| Se Woong Kim, PhD | Catholic Seoul medical center | Principal Investigator |
| Jae Suk Hyun, PhD | Gyeongsang National University Hospital | Principal Investigator |
| Je Jong Kim, PhD | Korea University | Principal Investigator |
| Nam Cheol Park, PhD | Pusan National University Hospital | Principal Investigator |
| Sung Won Lee, PhD | Samsung Medical Center | Principal Investigator |
| Jae Seung Paick, PhD | Seoul National University Hospital | Principal Investigator |
| Tae young Ahn, PhD | Asan Medical Center | Principal Investigator |
| Ki Hak Moon, PhD | Yeungnam University Hospital | Principal Investigator |
| Woo Sik Chung, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk national university hospital | Jeonju | Cholabukdo | 561-712 | 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 |
|---|---|
| C553414 | avanafil |
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| Avanafil | Drug | 2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse |
|
| Placebo | Drug | 2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse |
|
| Ewha womans university hospital |
| Principal Investigator |
| Kweon Sik Min, PhD | Inje university Pusan paick hospital | Principal Investigator |
| Jun Kyu Suh, PhD | Inha University Hospital | Principal Investigator |
| Kwang Sung Park, PhD | Chonnam National University Hospital | Principal Investigator |
| Dae Yul Yang, PhD | Kangdong Sacred Heart Hospital | Principal Investigator |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |