Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

Study Overview
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Brief Summary
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This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.

Detailed Description
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740 girls with CPP and EP participated in this study, all participates were divided into GnRHa group, traditional chinese medicines group and blank group. After at least six months therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical parameters, sex hormone, bone age and ovarian ultrasound in three groups.

Official Title
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Multi-site Study of Comprehensive Treatment for Children Precocious Puberty

Conditions
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Central Precocious Puberty

Intervention / Treatment
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* Drug: Triptorlin or Leuprorelin
* Drug: Zhibo dihuang pills
* Drug: Dabu ying pills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation. Accelerated linear growth: the annual growth rate is higher than normal. Advanced bone age: the bone age is 1 or years more than the actual age Enlargement of sexual glands: B-mode ultrasonography of pelvic cavity indicates the volumes of the uterus and ovaries have increased, and multiple ovarian follicles with a diameter>4mm can be found in ovaries; HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values. Subjects should be willing and able to follow the study protocol during the study period. Subjects should submit their parents' or guardians' written informed consent before initiation of the study procedure with non-normal medical care. They should understand that subjects or their parents/guardians may withdraw the consent at any time without impairing future medical care. If the child is old enough to read and write, she should submit a separate consent form. Exclusion Criteria: Patients with central nervous system diseases and thyroid diseases; Patients with CHA-induced precocious puberty; Patients with poor compliance.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRHa(Triptorlin or Leuprorelin)<br>Triptorlin or Leuprelin 100ug/kg per 28 days | Drug: Triptorlin or Leuprorelin<br>* Gonadotrophin releasing hormone agonists (GnRHa)<br>* Other names: Leuprorelin;|
| Active Comparator: Traditional Chinese Medicines<br>Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months | Drug: Zhibo dihuang pills<br>* Traditional Chinese Medicine<br>Drug: Dabu ying pills<br>* Traditional Chinese Medicine<br>|
| No Intervention: blank group<br>without therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of height SDS in the GnRHa group (n=202) is lower than in the traditional chinese medicines group (n=155) ,(P<0.05). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of breast stages in the GnRHa group (n=181) is lower than in the traditional chinese medicines group (n=148) ,(P<0.05). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidemiology, treatment, molecular pathological mechanism, environmental disrupting chemicals