Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487143
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-20
Brief Title:
Efficacy Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
The Effects of the 3-month Formulation of Triptorelin TP Compared to the 1-month Formulation on the Efficacy Glucose and Lipid Metabolism and Bone Mineral DensityBMD in Idiopathic Central Precocious PubertyICPP
Status:
NOT_YET_RECRUITING
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 primary objective of this study is to compare the efficacy of the 3-month formulation and 1-month formulation of triptorelin and to assess the short-term effects of the 3-month formulation of triptorelin on glucose and lipid metabolism body composition and bone density in Chinese ICPP patients
Detailed Description:
Idiopathic central precocious puberty CPP is an important treatable disease causing pubertal growth disorders Gonadotropin-releasing hormone analogs GnRHa are the first-line drugs for treating idiopathic central precocious puberty ICPP Currently the 1-month formulation 375mg is the most widely used in China The development of long-acting formulations will reduce the number of injections and treatment costs for children as well as reduce the clinical visit burden The 3-month formulation of Triptorelin Pamoate 15mg was approved for use in central precocious puberty in March 2023 At present there is only one publicly reported small-sample single-arm clinical study in China and there are no large-sample real-world concurrent controlled clinical study data on the efficacy and safety of the 3-month and 1-month formulations of triptorelin in the treatment of central precocious puberty In currently reported safety events both domestically and internationally there are no reports on the effects of the 3-month formulation of triptorelin on patients glucose and lipid metabolism body composition and bone density Our research team previously observed in a small-sample retrospective study of female patients with ICPP that after 1 year of treatment with the 3-month formulation of GnRHa 1125mg leuprorelin it effectively inhibited the hypothalamic-pituitary-gonadal axis and bone age progression improved predicted adult height and had no serious safety events Therefore based on our previous work we plan to conduct a large-sample real-world concurrent controlled study to evaluate the gonadal axis suppression and predicted adult height benefits of the 3-month formulation of triptorelin compared to the 1-month formulation in patients with central precocious puberty CPP Additionally we will assess the short-term effects of the 3-month formulation of triptorelin on glucose and lipid metabolism body composition and bone density in ICPP patients The study results are expected to provide clinical evidence for the application of the 3-month formulation in the treatment of central precocious puberty in China
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?:
False
Is an FDA AA801 Violation?:
None