Puberty, Central Precocious Clinical Trial
An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty
The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.
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. ;
|Start date||June 24, 2017|
|Completion date||September 30, 2018|