← Back to Search

Hormone Therapy

Growth Hormone Therapy for Human Growth Hormone Deficiency

Phase 2

Recruiting

Led By Randall R Benson, MD

Research Sponsored by Center for Neurological Studies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 76 years of age

Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 1-year post-treatment

Awards & highlights

Study Summary

This trial is testing whether growth hormone can improve cognitive function in retired professional football players with growth hormone deficiency.

Who is the study for?

This trial is for retired NFL players under 76 years old with growth hormone deficiency (GHD) diagnosed by a neurologist and endocrinologist. They must understand the study, be willing to participate, and have been retired for at least one year. Those with diabetes, pre-existing brain diseases other than concussion or TBI, conditions affecting assessments, contraindications to GH therapy, active cancer, acute illnesses or untreated hormonal deficiencies cannot join.Check my eligibility

What is being tested?

The trial tests if growth hormone (GH) improves cognitive functions in these athletes compared to a placebo. Participants are randomly assigned to receive either GH or placebo without knowing which they're getting. After this phase ends, there's an open-label extension where everyone knows they're receiving GH.See study design

What are the potential side effects?

Possible side effects of growth hormone therapy include joint pain, swelling due to fluid in the body's tissues (edema), carpal tunnel syndrome-like symptoms such as numbness and tingling of the hands and fingers, muscle pain and increased cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am younger than 76 years old.

Select...

I have been diagnosed with growth hormone deficiency by both a neurologist and an endocrinologist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 1-year post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 1-year post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1-year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)

Cognitive functions- Executive Function.

Cognitive functions- Processing Speed

+2 more

Secondary outcome measures

Adverse events

Change in Physical function- Isokinetic knee extension peak torque

Change in Physical function- Maximum grip strength

+6 more

Other outcome measures

MR imaging analysis of hypothalamus and pituitary

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Growth HormoneExperimental Treatment1 Intervention

Norditropin® (somatropin [rDNA origin] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).

Group II: SalinePlacebo Group1 Intervention

Saline-placebo via auto-injector pens (Haselmeier Inc).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Somatotropin

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Neurological StudiesLead Sponsor

Novo Nordisk A/SIndustry Sponsor

1,514 Previous Clinical Trials

2,415,026 Total Patients Enrolled

6 Trials studying Human Growth Hormone Deficiency

228 Patients Enrolled for Human Growth Hormone Deficiency

Randall R Benson, MDPrincipal InvestigatorVice President and Medical Director

Media Library

Growth Hormone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04121780 — Phase 2

Human Growth Hormone Deficiency Research Study Groups: Growth Hormone, Saline

Human Growth Hormone Deficiency Clinical Trial 2023: Growth Hormone Highlights & Side Effects. Trial Name: NCT04121780 — Phase 2

Growth Hormone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04121780 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the antecedents of this research project?

"As of now, 35 different independent research groups are conducting clinical trials for Growth Hormone in 170 cities and 45 countries. The very first study was completed by BioPartners GmbH in 2005; it reached the third stage of drug approval after involving 144 patients. In total, 18477 studies have been undertaken since then."

Answered by AI

Which medical disorders are most likely to be helped by Growth Hormone therapy?

"Growth Hormone is not only used as a general surgery treatment, but also for other conditions such as short stature and open epiphyses. Additionally, it is sometimes given to patients undergoing antiretroviral therapy."

Answered by AI

Does research on Growth Hormone date back far?

"Right now, 35 research studies concerning Growth Hormone are ongoing. Of these active investigations, 14 have progressed to Phase 3 clinical trials. Though a few of the experiments are situated in Philadelphia, Pennsylvania, there are 646 total locations running Growth Hormone trials."

Answered by AI

What goals does this research hope to achieve?

"The primary outcome of this study will be evaluated over a From baseline to 1-year post-treatment time frame and is related to Cognitive functions- Processing Speed. Secondary outcomes include Change in Physical function- Peak O2 consumption (Vo2 max), which is defined as Measured in units of liters per minute, and Change in QEEG Markers- power spectra, which is defined as Spectral markers include delta (1-5-2.5 Hz), theta (3.5-7.5 Hz), alpha (7.5-12.5 Hz), alpha 1 (7.5-10"

Answered by AI

Are researchers still looking for participants in this clinical trial?

"That is correct, the trial information on clinicaltrials.gov says that the study is actively looking for subjects. The first posting was on 10/8/2019, and the most recent update was on 7/27/2021. They are searching for 42 patients at 1 location."

Answered by AI

How do I sign up for this experiment?

"This study, which is testing a new football injury treatment, will be working with 42 participants that meet the following age, sport, and health requirements: between 18 and 76 years old, must have retired from NFL football more than 1 year ago, cannot have any other diagnosed endocrine disorders."

Answered by AI

Could you explain the risks associated with Growth Hormone?

"There is some evidence that suggests Growth Hormone is safe, but none regarding efficacy. This medication received a score of 2."

Answered by AI

Are adolescent patients eligible for this trial?

"To be eligible for this particular clinical trial, applicants must between 18 and 76 years old. Out of the 982 total studies, 221 are solely for minors while 761 are for senior citizens."

Answered by AI