A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)
NCT00816712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2015-02-13
Summary
This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).
Conditions
- Muscle Anabolism
Interventions
- DRUG
-
Comparator: Testosterone 300 mg, intramuscular injection
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.
- DRUG
-
Comparator: Testosterone 100 mg, Intramuscular injection
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.
- DRUG
-
Comparator: Placebo given by Intramuscular Injection
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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
More Related Trials
-
The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men
NCT01417364 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy of an Intranasal Testosterone Product
NCT01252745 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Testosterone Replacement on Insulin Resistance
NCT00487734 ·Status: COMPLETED ·Phase: PHASE4
-
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
NCT04439799 ·Status: COMPLETED ·Phase: PHASE4
-
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
NCT01703741 ·Status: COMPLETED ·Phase: PHASE3
-
Subcutaneous vs. Intramuscular Testosterone
NCT03091348 ·Status: COMPLETED ·Phase: PHASE4
-
PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
NCT01327495 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma
NCT00631137 ·Status: TERMINATED ·Phase: NA
-
Testosterone Replacement in Metabolic Syndrome and Inflammation
NCT01123278 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen
NCT04545450 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
NCT03864913 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
NCT01104246 ·Status: COMPLETED ·Phase: PHASE1
-
Oral T7 Oral Testosterone in Man
NCT00842751 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
NCT01446042 ·Status: COMPLETED ·Phase: PHASE3
-
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
NCT00161421 ·Status: COMPLETED ·Phase: PHASE2
-
Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients
NCT00965341 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
NCT02149264 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic Study of Testosterone Enanthate
NCT01887418 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
NCT02159469 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
NCT04456530 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
NCT07278362 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?
NCT05964920 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Time to Eugonadal Range, Time to Steady State and Drying Time
NCT01228071 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Pharmacokinetics and Safety of Testosterone
NCT01370369 ·Status: COMPLETED ·Phase: PHASE2
-
Study of The Effects of Testosterone in Frail Elderly Men
NCT00190060 ·Status: COMPLETED ·Phase: PHASE4