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Growth Hormone Replacement Therapy for Retried Professional Football Players

NCT04121780 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-02-08

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

Conditions

  • TBI (Traumatic Brain Injury)
  • Concussion, Brain
  • Sport Injury
  • Anterior Pituitary Hyposecretion Syndrome
  • Hypopituitarism
  • Growth Hormone Deficiency

Interventions

BIOLOGICAL

Growth Hormone

Daily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase

OTHER

Placebo

Daily self-injections by subjects: 1-year double-blind phase

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Center for Neurological Studies

    lead OTHER

Principal Investigators

  • Randall R Benson, MD · Vice President and Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2025-03-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04121780 on ClinicalTrials.gov