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Study of Testosterone and rHGH in FSHD (STARFISH)

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ClinicalTrials.gov Identifier: NCT03123913
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Chad Heatwole, University of Rochester

April 12, 2017
April 21, 2017
January 9, 2018
December 18, 2017
July 2020   (Final data collection date for primary outcome measure)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 36 weeks ]
Safety and tolerability are monitored by interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations. Patients will report any adverse events through in-person and telephone evaluations as well as on patient diaries.
Same as current
Complete list of historical versions of study NCT03123913 on ClinicalTrials.gov Archive Site
  • Serum levels of free and total testosterone, IGF-1, thyroid function, luteinizing hormone and follicle stimulating hormone [ Time Frame: 36 weeks ]
    Serum levels of free and total testosterone, IGF-1, thyroid function, luteinizing hormone and follicle stimulating hormone will be assessed at each study visit.
  • Lean body mass [ Time Frame: 36 weeks ]
    Lean body mass will be measured at study visits through dual energy x-ray absorptiometry (DEXA) studies.
Same as current
  • Ambulation [ Time Frame: 36 weeks ]
    Ambulation will be assessed as an exploratory measure with the Six Minute Walk Test.
  • Strength [ Time Frame: 36 weeks ]
    Strength will be assessed as an exploratory measure with manual muscle testing and quantitative muscle testing.
  • Pulmonary Function [ Time Frame: 36 weeks ]
    Pulmonary function will be assessed as an exploratory measures with forced vital capacity testing.
  • Patient-Reported Disease Burden [ Time Frame: 36 weeks ]
    Patient-reported disease burden will be assessed as an exploratory measure with the FSHD-Health Index, PROMIS-57, Beck Depression Inventory, Epworth Sleepiness Scale, Fatigue Severity Scale, and International Prostate Symptoms Score.
Same as current
 
Study of Testosterone and rHGH in FSHD
Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study
The purpose of this study is to investigate the safety and tolerability of combination therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.
This is a single-center, open-label study of daily human growth hormone (Genotropin®, 5.0 μg/kg via subcutaneous injection) and testosterone (testosterone enanthate, 140mg via intramuscular injection every two weeks) for 24 weeks in men with FSHD with a 12 week washout period. A total of 20 subjects will be enrolled at the University of Rochester Medical Center in Rochester, NY.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Facioscapulohumeral Muscular Dystrophy
  • Drug: Testosterone Enanthate
    Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
    Other Names:
    • Delatestryl
    • Tesostroval
    • Testro LA
    • Andro LA
    • Durathate
    • Everone
    • Testrin
    • Andropository
    • Testosterone heptanoate
  • Drug: Somatropin
    Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
    Other Names:
    • Genotropin
    • Humatrope
    • Norditropin
    • Nutropin
    • Serostim
    • Zorbtive
Experimental: Combination therapy
Testosterone Enanthate and Somatropin
Interventions:
  • Drug: Testosterone Enanthate
  • Drug: Somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
July 2020
July 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A genetically confirmed diagnosis of FSHD (or clinical symptoms suggestive of FSHD with a first degree relative with genetically confirmed FSHD)
  • 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:

  • Diabetes
  • 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.
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact: Elizabeth A Luebbe, MS 585-275-7867 elizabeth_luebbe@urmc.rochester.edu
United States
 
 
NCT03123913
1R01NS095813-01( U.S. NIH Grant/Contract )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Chad Heatwole, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Chad R Heatwole, MD, MS-CI University of Rochester
University of Rochester
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP