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To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Testosterone Gel 1.62% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Gel 1.62% | Drug | 5 grams administered using an application Site Rotation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration observed (Cmax) | Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days |
| Area Under the Plasma Concentration-time Curve (AUC) | Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days |
| Time of Cmax (Tmax) | Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days |
| Average Plasma Concentration observed (Cav) | Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Application site evaluation based on the clinical evaluation of skin reactions grading scale | 24 days | |
| Adverse events | 24 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 |
|---|---|---|---|
| 21492400 | Result | Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011 Jul;8(7):2079-89. doi: 10.1111/j.1743-6109.2011.02265.x. Epub 2011 Apr 14. |
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| Testosterone Gel 1.62% |
| Drug |
5 grams administered using an a combination of Application sites |
|
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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