CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Testosterone Enanthate +1 moredrug
Likely dose
Testosterone enanthate 140 mg intramuscular injection every 2 weeks and somatropin (Genotropin) 5.0 μg/kg/day subcutaneous injectionAI-extracted
Key inclusion· 6
  • ✓Genetically confirmed FSHD or clinical FSHD symptoms with a first-degree relative with genetically confirmed FSHD
  • ✓Able to walk continuously for 6 minutes (cane, walker, orthoses allowed)
  • ✓Able to independently administer or have family member administer intramuscular and subcutaneous injections
  • ✓Hematocrit ≤50%
Key exclusion· 15
  • ✕Diabetes
  • ✕Obesity (BMI >35 kg/m²)
  • ✕Cardiovascular disease including heart failure, coronary artery disease, uncontrolled hypertension, or untreated hypercholesterolemia
  • ✕Untreated thyroid disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03123913
NCT03123913Phase 1Completed
CompareCT.gov

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

University of Rochester·interventional·Posted Apr 21, 2017·Updated May 16, 2023

In Brief

A Phase 1 clinical trial evaluating Testosterone Enanthate and Somatropin for Facioscapulohumeral Muscular Dystrophy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacioscapulohumeral Muscular Dystrophy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartDec 18, 2017
Primary CompletionMar 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.2 years ago

Interventions

Testosterone Enanthatedrug

Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.

Somatropindrug

Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.