Status:
COMPLETED
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Lead Sponsor:
Takeda
Conditions:
Central Precocious Puberty
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE4
Brief Summary
The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months...
Detailed Description
The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at t...
Eligibility Criteria
Inclusion
- Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years
- Body weight ≥20 kg
- According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level \>5.0 IU/L with LH/FSH \>0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening.
Exclusion
- The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent.
- The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
- The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
- The participant has a diagnosis of peripheral precocious puberty.
Key Trial Info
Start Date :
March 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05341115
Start Date
March 14 2023
End Date
March 10 2025
Last Update
May 16 2025
Active Locations (5)
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1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100033
2
the First A liated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510062
3
The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University.
Wuhan, Hubei, China, 430030
4
Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250021