Last updated: February 5, 2024
Sponsor: Children's Hospital of Fudan University
Overall Status: Completed
Phase
4
Condition
N/ATreatment
Ziyinxiehuo Granules Herbs
Leuprorelin Acetate 3.75mg Injection
Megestrol Acetate Tablet
Clinical Study ID
NCT03963752
18401902300
Ages 5-8 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Girls are diagnosed as Idiopathic central precocious puberty by GnRH (gonadotrophinreleasing hormone)Stimulation Test, and their age of onset ≤8 years;
- Tanner stages of breast in female patients ≥ Tanner III stage,diameter of mammillarynucleus ≥ 3cm;
- B-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, thediameter of follicle≥4mm;
- Bone age: compared the chronological age, the bone age is more than 1 year and thebone age <11.5 years old;
- It progresses rapidly, ratio of bone age difference to chronological age difference> 1;
- No GnRH analogs or sex hormones were administrated in the past;
- All above are needed at the same time.
Exclusion
Exclusion Criteria:
- Precocious precocity caused by the central nervous system organic diseases;
- Precocious precocity caused by congenital hypothyroidism, congenital adrenalhyperplasia, adrenal tumor and ovarian or testicular neoplasms as well asMcCune-Albright syndrome, etc;
- Precocious precocity with a family history of diseases such as tumor, leukemia,diabetes, systemic lupus erythematous;
- Pseudo sexual precocity and partial precocious puberty.
Study Design
Total Participants: 126
Treatment Group(s): 3
Primary Treatment: Ziyinxiehuo Granules Herbs
Phase: 4
Study Start date:
August 15, 2019
Estimated Completion Date:
September 30, 2022
Study Description
Connect with a study center
Children's Hospital of Fudan University
Shanghai, Shanghai 201102
ChinaSite Not Available
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