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A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

Central Precocious Puberty Clinical Trial

Official title:
An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty

Clinical Trial Summary

The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).

Clinical Trial Description

The drug in this study is called leuprorelin. It is administered as a 1 month subcutaneous depot injection. Leuprorelin is used to treat children who have CPP. This study will look at whether leuprorelin can stop early puberty in pre-pubertal children. The study will enroll approximately 300 participants. Participants with body weight >=20 kg will receive the recommended dose of leuprorelin 3.75 mg subcutaneous injection every 4 weeks for 96 weeks. Participants with body weight <20 kg will receive recommended dose of 1.88 mg subcutaneous injection every 4 weeks for 96 weeks. This trial will be conducted in China. The overall time to participate in this study is 104 weeks. Participants will make 11 visits to the clinic, and will be followed-up by the physician on a long-term basis until stable puberty is reached. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02427958
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 4
Start date August 7, 2015
Completion date November 23, 2018
View Details
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