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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_693 | |||
| MK-0773-004 |
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This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0773 + placebo injection |
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| 2 | Active Comparator | placebo to MK0773 + testosterone injection |
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| 3 | Placebo Comparator | placebo to MK0773 + placebo injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0773 | Drug | Three 25mg oral tablets MK0773 bid, for 12 weeks |
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| Comparator: testosterone enanthate |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Clinical Adverse Events (CAE) | 12 weeks | |
| Number of subjects with Serious CAEs | 12 weeks | |
| Number of subjects with drug-related CAEs | 12 weeks | |
| Number of subjects with serious drug-related CAEs | 12 weeks | |
| Number of subjects that discontinued with CAEs | 12 weeks | |
| Number of subjects with Laboratory Adverse Events (LAE) | 12 weeks | |
| Number of subjects with drug-related LAEs | 12 weeks | |
| Number of subjects with serious LAEs | 12 weeks | |
| Number of subjects with serious drug-related LAEs | 12 weeks | |
| Number of subjects that discontinued with LAEs | 12 weeks |
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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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| ID | Term |
|---|---|
| C550076 | 3-fluoro-N-(3H-imidazo(4,5-b)pyridin-2-ylmethyl)-1,4a,6a-trimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno(5,4-f)quinoline-7-carboxamide |
| C004648 | testosterone enanthate |
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| Drug |
intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks |
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| Comparator: placebo oral tablet | Drug | placebo oral tablet bid, for 12 weeks |
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| Comparator: placebo injection | Drug | placebo intramuscular injection q14d, for 12 weeks |
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