Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Recruiting Phase 3 Interventional Study
Adult Growth Hormone Deficiency Mild Traumatic Brain Injury
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 55
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
172 (estimated)
Sponsor
VA Office of Research and Development · Federal
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About This Trial

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. OEF/OIF/OND Veteran 2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2) 3. Age 21 - 55 years old 4. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CR…
Contacts

Deane V Walker, MHA BS AB

(203) 937-3440

Deane.Walker@va.gov

CONTACT

Michael T Wininger, PhD

(203) 932-5711

michael.wininger@va.gov

CONTACT