Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency
Who is this study for? Retired professional football players with growth hormone deficiency
What treatments are being studied? Growth Hormone
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 76
Healthy Volunteers: f
View:
• 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
Locations
United States
Michigan
Center for Neurolgoical Studies (CNS)
RECRUITING
Dearborn
Contact Information
Primary
Vijay M Baragi, Ph.D.
vijay@neurologicstudies.com
313-228-0930.
Backup
John Russell
JDR@neurologicstudies.com
3132280930
Time Frame
Start Date: 2019-10-08
Estimated Completion Date: 2026-09
Participants
Target number of participants: 42
Treatments
Experimental: Growth Hormone
Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
Placebo_comparator: Saline
Saline-placebo via auto-injector pens (Haselmeier Inc).
Related Therapeutic Areas
Sponsors
Leads: Center for Neurological Studies
Collaborators: Novo Nordisk A/S