NCT03123913

Study of Testosterone and rHGH in FSHD

Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Facioscapulohumeral Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	Testosterone Enanthate	Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
DRUG	Somatropin	Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.

Timeline

• Start date: 2017-12-18
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2017-04-21
• Last updated: 2023-05-16
• Results posted: 2023-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study