Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355030
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2006-07-18
Brief Title:
Somatropin Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Phoenix
Brief 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 clinicaltrialsgov Identifier NCT01088412 for long term safety follow up independent of this study
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 clinicaltrialsgov Identifier NCT01088412 for long term safety follow up independent of this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B9R-FP-GDGI | OTHER | Eli Lilly and Company | None |