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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVDI |
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| Name | Class |
|---|---|
| ICOS Corporation | INDUSTRY |
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Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo tablet |
|
| 2 | Active Comparator | 5 mg tadalafil |
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| 3 | Active Comparator | 10 mg tadalafil |
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| 4 | Active Comparator | 20 mg tadalafil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil | Drug | 5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint of various questions from the IIEF and SEP diary | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sapporo | Hokkaido |
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| placebo | Drug | placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks |
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| tadalafil | Drug | 10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks |
|
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| tadalafil | Drug | 20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks |
|
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| Japan |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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