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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_604 |
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This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Testosterone - 300 mg IM |
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| B | Active Comparator | Testosterone - 100 mg IM |
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| C | Placebo Comparator | Placebo - IM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Testosterone 300 mg, intramuscular injection | Drug | Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Testosterone 300 mg, Intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Variability in the muscle fractional synthetic rate measurements. | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21475673 | Result | Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26. |
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| Comparator: Testosterone 100 mg, Intramuscular injection | Drug | Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Testosterone 100 mg, Intramuscular injection. |
|
| Comparator: Placebo given by Intramuscular Injection | Drug | Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Placebo given as intramuscular injection. |
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| ID | Term |
|---|---|
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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