Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2017-12-18
2022-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination therapy
Testosterone Enanthate and Somatropin
Testosterone Enanthate
Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin
Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
Interventions
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Testosterone Enanthate
Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Somatropin
Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hematocrit of ≤ 50%
* Prostate-specific antigen ≤ 4.0 ng/ml (or ≤ 3.0 ng/ml if the participant has a first-degree relative with prostate cancer)
* Fasting blood glucose \<126 mg/dl
* Able to walk continuously for six minutes (cane, walker, orthoses allowed)
* Able to independently administer intramuscular and subcutaneous injections (or have a family member who is capable and willing to administer these injections)
Exclusion Criteria
* Obesity (BMI\>35 kg/m2)
* Cardiovascular disease (heart failure, coronary artery disease, uncontrolled hypertension, untreated hypercholesterolemia)
* Untreated thyroid disease
* Deep vein thrombosis
* Untreated severe sleep apnea
* Past pituitary disease
* Significant musculoskeletal injury and/or pain that affects walking
* A systolic blood pressure over 160 or a diastolic pressure over 100
* Plans to dramatically change exercise habits
* Liver disease
* Renal disease
* Cancer (other than basal cell skin cancer)
* Plans to conceive
* Heavy alcohol use (greater than 50g/day)
* Current testosterone or HGH use
* Current use of medications that interfere with the growth hormone or gonadal endocrine axis.
18 Years
65 Years
MALE
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Chad Heatwole
Professor of Neurology
Principal Investigators
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Chad R Heatwole, MD, MS-CI
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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References
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Heatwole CR, Luebbe E, Hamel J, Mongiovi PC, Ciafaloni E, Dilek N, Martens WB, Weber DR, Rashid H, Allen McKeown J, Smith CH, Howell S, Rosero SZ, Eichinger K, Baker LS, Dekdebrun JM, Hilbert JE, Varma A, Thornton CA, McDermott MP, Moxley RT 3rd. Study of Testosterone and Recombinant Human Growth Hormone in Facioscapulohumeral Muscular Dystrophy. Neurol Genet. 2025 Aug 27;11(5):e200292. doi: 10.1212/NXG.0000000000200292. eCollection 2025 Oct.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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