Clinical Trial: Study of Testosterone and rHGH in FSHD

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: University of Rochester

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University of Rochester

Dates:
Date Received: April 12, 2017
Date Started: July 2017
Date Completion: July 2020
Last Updated: April 14, 2017
Last Verified: April 2017