Growth Hormone Replacement Therapy for Retried Professional Football Players (NCT04121780) | Clinical Trial Compass
RecruitingPhase 2
Growth Hormone Replacement Therapy for Retried Professional Football Players
United States42 participantsStarted 2019-10-08
Plain-language 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).
Who can participate
Age range
18 Years – 76 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.
* Former NFL player
* At least one year since retirement from football
* Less than 76 years of age
* Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD
Exclusion Criteria:
* History of pre-existing brain disease other than concussion or TBI
* History of a premorbid disabling condition that interferes with outcome assessments
* Contraindication to GH therapy
* Type I and II Diabetes mellitus
* Active malignant disease
* Acute critical illness, heart failure, or acute respiratory failure
* Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive functions- Working Memory
Timeframe: From baseline to 1-year post-treatment
2
Cognitive functions- Processing Speed
Timeframe: From baseline to 1-year post-treatment
3
Cognitive functions- Executive Function.
Timeframe: From baseline to 1-year post-treatment
4
Cognitive functions- Verbal learning and memory
Timeframe: From baseline to 1-year post-treatment
5
Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)