Idiopathic Short Stature (ISS) Clinical Trial
Official title:
Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature
The present randomized trial was initially intended to study the benefits of a combined
treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for
pubertal children with idiopathic short stature. However, treatments were stopped in January
2012 at the request of the French drug agency. Therefore, a protocol amendment divided the
study in two study periods.
Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with
somatropin alone. Participants from France who participated in this Period 1 of the study
were asked to participate in a long term safety follow up defined as a Period 2 of the study.
Participants from the Netherlands were offered participation in Genetics and
Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov
Identifier: NCT01088412) for long term safety follow up independent of this study.
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