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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVDY |
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| Name | Class |
|---|---|
| ICOS Corporation | INDUSTRY |
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Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | 10 mg tadalafil tablet |
|
| 3 | Active Comparator | 20 mg tadalafil tablet |
|
| 1 | Placebo Comparator | placebo tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil | Drug | 10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. | 4, 8, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF questions and scores, Global Assessment Questions, Patient's 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 to your personal physician. | Beijing | China |
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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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| tadalafil | Drug | 20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day |
|
|
| placebo | Drug | placebo tablet taken by mouth as needed for 12 weeks not more than once a day |
|
| 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 |