NCT02427958

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 1 Year – 9 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Leuprorelin	Suspension for injection.

Timeline

• Start date: 2015-08-07
• Primary completion: 2018-11-23
• Completion: 2018-11-23
• First posted: 2015-04-28
• Last updated: 2022-03-16
• Results posted: 2019-07-24

Locations

9 sites across 1 country: China