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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00812396 |
This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.
Condition | Intervention | Phase |
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Muscle Anabolism |
Drug: Comparator: low dose testosterone Drug: Comparator: high dose testosterone Drug: Comparator: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism |
Enrollment: | 30 |
Study Start Date: | November 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Low dose testosterone
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Drug: Comparator: low dose testosterone
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.
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2: Active Comparator
High dose testosterone
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Drug: Comparator: high dose testosterone
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.
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3: Placebo Comparator
Placebo
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Drug: Comparator: placebo
Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_602, 082 |
Study First Received: | December 19, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00812396 |
Health Authority: | Ireland: Irish Medicines Board |
Biomarkers of muscle anabolism |
Testosterone Methyltestosterone Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |