MedTrace Logo

Study of Testosterone and rHGH in FSHD

NCT03123913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Chad R Heatwole, MD, MS-CI · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2022-03-28
Completion
2022-03-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123913 on ClinicalTrials.gov