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Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

Central Precocious Puberty Clinical Trial

Official title:
An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 3-month Formulation in Chinese Children With Central Precocious Puberty

Clinical Trial Summary

The purpose of this study is to observe whether the Triptorelin pamoate 15mg (3-month formulation) effectiveness in Chinese population of CPP children has the same or similar trend with that in overseas CPP population. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection of triptorelin.

Clinical Trial Description

For patients enter extension phase, two additional Triptorelin injections will be given at month 6 and month 9 visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04736602
Study type Interventional
Source Ipsen
Contact
Status Completed
Phase Phase 3
Start date March 27, 2021
Completion date September 3, 2022
View Details
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