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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2024 |
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Main ID: |
NCT03963752 |
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Date of registration:
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22/05/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
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Scientific title:
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Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine |
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Date of first enrolment:
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August 15, 2019 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03963752 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Jian Yu, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Fudan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Girls are diagnosed as Idiopathic central precocious puberty by GnRH (gonadotrophin
releasing hormone)Stimulation Test, and their age of onset =8 years;
- Tanner stages of breast in female patients = Tanner III stage,diameter of mammillary
nucleus = 3cm;
- B-type ultrasonography: the volume of uterus=3ml, the volume of ovary=1.5ml, the
diameter of follicle=4mm;
- Bone age: compared the chronological age, the bone age is more than 1 year and the
bone 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 Criteria:
- Precocious precocity caused by the central nervous system organic diseases;
- Precocious precocity caused by congenital hypothyroidism, congenital adrenal
hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as
McCune-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.
Age minimum:
5 Years
Age maximum:
8 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Idiopathic Precocious Puberty
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Intervention(s)
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Drug: Megestrol Acetate Tablet
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Drug: Leuprorelin Acetate 3.75mg Injection
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Drug: Ziyinxiehuo Granules Herbs
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Primary Outcome(s)
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Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
[Time Frame: After six months of continuous treatment]
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Secondary Outcome(s)
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Ratio of bone age difference to chronological age difference
[Time Frame: After six months of continuous treatment]
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Secondary ID(s)
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18401902300
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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