Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers|
- serum concentrations of insulin-like growth factor-1 (IGF-1)
|Study Start Date:||August 2004|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Syntropin will be administered by subcutaneous injection. Eligible patients will receive a subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12 hours before, immediately prior to, and 12 hours after the scheduled injection of growth hormone.