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

Launched by TAKEDA · Dec 13, 2016

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has diagnosis of idiopathic CPP.
• • 2. Has been treated with leuprorelin acetate (Enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to \[\>=\] 90 mcg/kg up to 180 mcg/kg) or low dose (\< 90 mcg/kg down to 30 mcg/kg).
• • 3. Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
• • 4. Have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: Tanner staging, estradiol or testosterone level, and FSH and LH level. The participant should have at least one record of bone age prior to the initiation gonadotropin releasing hormone analogs (GnRHa) therapy with enantone to support the diagnosis of CPP. In addition, should have at least one record of bone age during treatment with enantone.
• Exclusion Criteria:
• • 1. Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
• • 2. Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
• • 3. CPP participants with identified etiology, such as brain tumor or cranial irradiation.