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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 : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chad Heatwole, University of Rochester

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE December 18, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03123913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 14, 2017)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Testosterone and rHGH in FSHD
Official Title  ICMJE Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Facioscapulohumeral Muscular Dystrophy
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Combination therapy
Testosterone Enanthate and Somatropin
Interventions:
  • Drug: Testosterone Enanthate
  • Drug: Somatropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth A Luebbe, MS 585-275-7867 elizabeth_luebbe@urmc.rochester.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03123913
Other Study ID Numbers  ICMJE 1R01NS095813-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chad Heatwole, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chad R Heatwole, MD, MS-CI University of Rochester
PRS Account University of Rochester
Verification Date March 2019

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