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Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Gel 1.62% | Drug | 5 grams |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration observed (Cmax) | Maximum plasma concentration observed (Cmax) of total testosterone | Up to 5 days |
| Area Under the Plasma Concentration-time Curve (AUC) | Area under the plasma concentration-time curve (AUC) of total testosterone | Up to 5 days |
| Average Plasma Concentration observed (Cav) | Average Plasma Concentration observed (Cav) of total testosterone | Up to 5 days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Miller, PharmD | Abbott | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22188558 | Result | Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24. |
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