Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study Design : multi-center, double-blind, placebo-controlled, randomized,
parallel group, fixed dose design
Phase : Phase III
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-8159 dose 1 | Experimental | Udenafil |
|
| DA-8159 dose 2 | Experimental | Udenafil |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8159 (Udenafil) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF EF domain score | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF, IPSS | 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| S W Kim, MD, PhD | the Catholic University of Korea St. Mary's Hospital | Principal Investigator |
| D G Moon, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| J J Kim, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| N C Park, MD, PhD | Pusan National University Hospital | Principal Investigator |
| S W Lee, MD, PhD | Samsung Medical Center | Principal Investigator |
| J S Paick, MD, PhD | Seoul National University Hospital | Principal Investigator |
| T Y Ahn, MD, PhD | Asan Medical Center | Principal Investigator |
| K H Moon, MD, PhD | Yeungnam University Hospital | Principal Investigator |
| W S Chung, MD, PhD | Ewha Womans University | Principal Investigator |
| K S Min, MD, PhD |
Not provided
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
Not provided
Not provided
| ID | Term |
|---|---|
| C419664 | udenafil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Inje University |
| Principal Investigator |
| J K Park, MD, PhD | Chonbuk National University Hospital | Principal Investigator |
| D Y Yang, MD, PhD | Kangdong Sacred Heart Hospital | Principal Investigator |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |