NCT02993926

A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants

An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.

Detailed description

The drug being evaluated in this study is called Enantone (leuprorelin). Enantone is used to treat children who have CPP. This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP. The study will enroll approximately 300 participants. All participants who have received leuprorelin 30 mcg/kg to \<90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed. This multi-center trial will be conducted in China. Data will be collected over period of 20 months.

Conditions

• Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Enantone	Enantone suspension for injection
DRUG	GnRH agonist	A non-Enantone GnRH agonist

Timeline

• Start date: 2017-06-24
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2016-12-15
• Last updated: 2022-03-16
• Results posted: 2019-10-24

Locations

6 sites across 1 country: China