A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
|ClinicalTrials.gov Identifier: NCT02427958|
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Puberty, Precocious||Drug: Leuprorelin||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||307 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty|
|Actual Study Start Date :||August 7, 2015|
|Actual Primary Completion Date :||November 23, 2018|
|Actual Study Completion Date :||November 23, 2018|
Participants with body weight greater than or equal to (>=) 20 kilogram (kg) will receive the recommended dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (<) 20 kg will receive leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks.
Suspension for injection.
Other Name: Enantone
- 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427958
|Beijing, Beijing, China|
|Wuhan, Hubei, China|
|Changsha, Hunan, China|
|Nanjing, Jiangsu, China|
|Wuxi, Jiangsu, China|
|Nanchang, Jiangxi, China|
|Changchun, Jilin, China|
|Shanghai, Shanghai, China|
|Hangzhou, Zhejiang, China|
|Study Director:||Medical Director||Takeda|