Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05029622
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2021-08-09
Brief Title:
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
A Phase III Open-label Multicentre Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR Prolonged Release formulation in suppressing LH Luteinising hormone levels to prepubertal levels defined as a peak LH 5 IUL after iv GnRH Gonadotropin-releasing Hormone stimulation at Month 6 Day 169 in Chinese children with CPP Central Precocious Puberty
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2022-003857-78 | EUDRACT_NUMBER | None | None |