The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
307
Suspension for injection.
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Beijing, Beijing Municipality, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 100
Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96
Tanner assessment score was used to document the stage of development of puberty through the assessment of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Regression or no progression was defined as negative change (improvement) or no change in Tanner score at Week 96 compared to baseline.
Time frame: Week 96
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Wuxi, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Shanghai, Shanghai Municipality, China
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Hangzhou, Zhejiang, China