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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
University of Rochester
Rochester, New York, United States
Number of Participants Who Experienced an AE
AEs were collected through patient report, interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations.
Time frame: 36 weeks
Mean Change in Level of Free Testosterone in the Blood
Time frame: Baseline to 24 weeks
Mean Change in Level of Total Testosterone in the Blood
Time frame: Baseline to 24 weeks
Mean Change in Level of IGF-1 in the Blood
Time frame: Baseline to 24 weeks
Mean Change in Level of TSH in the Blood
Time frame: Baseline to 24 weeks
Mean Change in Level of Luteinizing Hormone in the Blood
Time frame: Baseline to 24 weeks
Mean Change in Level of FSH in the Blood
Time frame: Baseline to 24 weeks
Mean Change in Total Lean Body Mass
Time frame: Baseline to 24 weeks
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