Status:
COMPLETED
A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Muscle Anabolism
Eligibility:
MALE
60-70 years
Phase:
PHASE1
Brief Summary
This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).
Eligibility Criteria
Inclusion
- Subject is weight stable over the past 3 months
- Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study
- Subject agrees to follow the study restriction of no caffeine while on study
- Patient agrees to following the meat-free controlled protein weight-maintaining diet
- Patient is willing to avoid strenuous physical activity
- Patient has been a nonsmoker for at least 6 months prior to study start
Exclusion
- Subject is currently a regular user of any illicit drugs
- Subject has taken androgenic steroids in the previous 12 months
- Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month
- Subject has prostate cancer
- Subject has a history of cancer except basal-cell tumors
- Subject has been diagnosed with HIV
- Subject has been diagnosed with Hepatitis B or C
- Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib
- Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin
- Subject is currently taking over the counter supplements such as "muscle builders" or "fat burners"
- Subject has an allergy or hypersensitivity to intramuscular testosterone
- Subject has sciatica
- Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent
- Subject has undergone a surgical procedure within 1 month of signing informed consent
- Subject is currently participating or has participated in a study with an investigational drug or device
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00816712
Start Date
January 1 2008
End Date
December 1 2008
Last Update
February 13 2015
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