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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVGC |
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| Name | Class |
|---|---|
| ICOS Corporation | INDUSTRY |
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Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control. |
|
| 2 | Active Comparator | Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil | Drug | Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) sum total of questions 1-7 | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. | 12 weeks | |
| Measure Uroflowmetry parameters | 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. | Chicago | Illinois |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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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|
| placebo | Drug | Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks. |
|
| Evaluate safety by PSA levels and postvoid residual volume (PVR) |
| 12 weeks |
| United States |
| D052801 |
| Male Urogenital Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |