Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
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.