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The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 2 | Active Comparator | Testosterone Spray (5%) vs Intrinsa® Patch |
|
| Cohort 3 | Active Comparator | Testosterone Spray (1%) vs Intrinsa® Patch |
|
| Cohort 1 | Active Comparator | Testosterone Spray (5%) vs Testosterone Spray (1%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Spray 5% and 1% | Drug | Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the amount of testosterone in the blood after dosing | The following PK parameters of testosterone will be measured AUC0-24, AUC0-48, AUC0-72, AUC0-96, Cavg, Cmin, Cmax | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Allison, MD | MDS Pharma Services Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services | Tempe | Arizona | 85283 | United States |
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| Intrinsa® Patch and Testosterone Spray 5% | Drug | Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days |
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| Intrinsa® Patch and Testosterone Spray 1% | Drug | Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days |
|
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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