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The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanomilled testosterone | Drug | |||
| Nanomilled dutasteride | Drug | |||
| commercially available dutasteride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine | days 1 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone concentration . | on days 1 and 28 | |
| Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride | days 1 and 28. | |
| Anabolic & androgenic Pharmacodynamic biomarkers |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, M.D., Ph.D., FACP | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Torrance | California | 90502 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 14, 2017 | |
| Reset | Mar 2, 2018 | |
| Release | Mar 23, 2018 |
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| pre- and post-dose |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| GSK Investigational Site | Baltimore | Maryland | 21287 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Seattle | Washington | 98108 | United States |
| GSK Investigational Site | Seattle | Washington | 98195 | United States |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2017 | Mar 2, 2018 | |||
| Mar 23, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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