The study was a controlled, multi-center study that randomized 43 SGA children to genotropin or an untreated control group. Participants were randomized in a 1:1 ratio to receive Genotropin 0.035mg/kg/day or no treatment. A total of 39 participants completed the study, with two Genotropin participants and two control-group participants withdrawing from the study.
The primary endpoint of the study was met with a statistically significant difference at 24 months in change from baseline height between patients treated with Genotropin vs. those in the untreated control group, as measured by height standard deviation score (SDS).
Genotropin is a man-made, prescription treatment option already approved for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). It is also approved to treat adults with growth hormone deficiency.
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