← Back to Search

Hormone Therapy

Testosterone Enanthate for Facioscapulohumeral Muscular Dystrophy (STARFISH Trial)

Phase 1
Waitlist Available
Led By Chad R Heatwole, MD, MS-CI
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights

STARFISH Trial Summary

This trial will study whether a combination of growth hormone and testosterone is safe and tolerable for men with FSHD over 24 weeks.

Eligible Conditions
  • Facioscapulohumeral Muscular Dystrophy

STARFISH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experienced an AE
Secondary outcome measures
Mean Change in Level of FSH in the Blood
Mean Change in Level of Free Testosterone in the Blood
Mean Change in Level of IGF-1 in the Blood
+4 more
Other outcome measures
Ambulation
Patient-Reported Disease Burden
Pulmonary Function
+1 more

Side effects data

From 2021 Phase 2 trial • 112 Patients • NCT02090114
57%
fatigue
40%
Musculoskeletal pain
37%
Increased Hemoglobin
23%
Hypertension
23%
nausea
17%
Anemia
17%
Breast Tenderness
17%
rash
17%
hot flashes
17%
cough
13%
weight loss
13%
gynecomastia
13%
pruritis
13%
edema
13%
dizziness
10%
constipation
10%
Creatinine Increased
10%
anorexia
10%
abdominal pain
10%
fall
10%
sinusitis
10%
headache
10%
High cholesterol
10%
eye discorder
7%
Syncope
7%
chest pain
7%
cold symptoms
3%
myocardial infarction
3%
insomnia
3%
diarrhea
3%
Acute Renal Insufficiency
3%
anxiety
3%
Elevated liver enzymes
3%
Elevated hematocrit
3%
Pancreatitis, elevated lipase, amylase
3%
gallstone
3%
fever
3%
Taster change
3%
Elevated potassium
3%
Shortness of breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A:Post-enzalutamide
Cohort B: Post-abiraterone
Cohort C: Castration Only
Cohort D: Mutation

STARFISH Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination therapyExperimental Treatment2 Interventions
Testosterone Enanthate and Somatropin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone Enanthate
2002
Completed Phase 4
~670
Somatropin
2015
Completed Phase 4
~67770

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
836 Previous Clinical Trials
518,148 Total Patients Enrolled
Chad R Heatwole, MD, MS-CIPrincipal InvestigatorUniversity of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Testosterone and rHGH in FSHD
Chad Heatwole 2017. "Study of Testosterone and rHGH in FSHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03123913.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top