Skip to content

Trial · Interventional

CompletedPhase 1Results postedRegistry data

Study of Testosterone and rHGH in FSHD

Short name STARFISH

NCTNCT03123913 (opens ClinicalTrials.gov in a new tab)Other id1R01NS095813-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
20 participants (actual)
Sponsor
University of Rochester · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
18 Dec 2017
Primary completion
28 Mar 2022
Completion
28 Mar 2022
First posted
21 Apr 2017
Last update posted
16 May 2023
Conditions
Facioscapulohumeral Muscular Dystrophy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020202120222023
  1. Ph 1

    STARFISH

    NCT03123913

    18 Dec 2017 to 28 Mar 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Testosterone EnanthateDrug
  • SomatropinDrug

Arms1

  • Experimental

    Combination therapy

    Testosterone Enanthate and Somatropin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Who Experienced an AE

    Time frame · 36 weeks

    Registry description

    AEs were collected through patient report, interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations.

Secondary outcomes(7)

  1. Mean Change in Level of Free Testosterone in the Blood

    Time frame · Baseline to 24 weeks

  2. Mean Change in Level of Total Testosterone in the Blood

    Time frame · Baseline to 24 weeks

  3. Mean Change in Level of IGF-1 in the Blood

    Time frame · Baseline to 24 weeks

  4. Mean Change in Level of TSH in the Blood

    Time frame · Baseline to 24 weeks

  5. Mean Change in Level of Luteinizing Hormone in the Blood

    Time frame · Baseline to 24 weeks

  6. Mean Change in Level of FSH in the Blood

    Time frame · Baseline to 24 weeks

  7. Mean Change in Total Lean Body Mass

    Time frame · Baseline to 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 36 weeks

Number of Participants Who Experienced an AE

GroupValue (Participants)
Combination Therapy14
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Level of Free Testosterone in the Blood

GroupValue (pg/mL)Spread
Combination Therapy17.4277.94
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Level of Total Testosterone in the Blood

GroupValue (ng/dL)Spread
Combination Therapy8.26277.94
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Level of IGF-1 in the Blood

GroupValue (ng/mL)Spread
Combination Therapy89.7971.57
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Level of TSH in the Blood

GroupValue (uIU/mL)Spread
Combination Therapy0.370.66
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Level of Luteinizing Hormone in the Blood

GroupValue (mIU/mL)Spread
Combination Therapy-3.482.64
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Level of FSH in the Blood

GroupValue (mIU/mL)Spread
Combination Therapy-3.294.47
Secondary outcomeMean· Baseline to 24 weeks

Mean Change in Total Lean Body Mass

GroupValue (Kg)Spread
Combination Therapy2.211.79

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Combination TherapyTestosterone Enanthate and Somatropin Testosterone Enanthate: Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks. Somatropin: Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.0 / 200 / 2020 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2025

Study of Testosterone and Recombinant Human Growth Hormone in Facioscapulohumeral Muscular Dystrophy.

Heatwole et al. 2025Neurology. Geneticscited by 3

PMID 40900971PMC12401552DOI 10.1212/nxg.0000000000200292PUB-40900971

Free to read · publisher termsCC BY-NC-ND
Read at source

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.