Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03123913
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2017-04-12
Brief Title:
Study of Testosterone and rHGH in FSHD
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Study of Testosterone and rHGH in FSHD STARFISH A Proof-of-Concept Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARFISH
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 50 μgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None