Study of Testosterone and rHGH in FSHD



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:3/8/2019
Start Date:December 18, 2017
End Date:July 2020
Contact:Elizabeth A Luebbe, MS
Email:elizabeth_luebbe@urmc.rochester.edu
Phone:585-275-7867

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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.

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.
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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