Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

Phase 4

Completed

• Conditions: Central Precocious Puberty
• Interventions: Drug: Triptorlin or Leuprorelin; Drug: Zhibo dihuang pills; Drug: Dabu ying pills

• Registration Number: NCT02920515
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2016-08-16
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-28
• Last Update Submitted: 2016-09-28
• Study First Posted: 2016-09-30
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 740

Inclusion Criteria

1. Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation.
2. Accelerated linear growth: the annual growth rate is higher than normal.
3. Advanced bone age: the bone age is 1 or years more than the actual age
4. 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;
5. HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values.
6. Subjects should be willing and able to follow the study protocol during the study period.
7. 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

1. Patients with central nervous system diseases and thyroid diseases;
2. Patients with CHA-induced precocious puberty;
3. Patients with poor compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRHa(Triptorlin or Leuprorelin)	Triptorlin or Leuprorelin	Triptorlin or Leuprelin 100ug/kg per 28 days
Traditional Chinese Medicines	Zhibo dihuang pills	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
Traditional Chinese Medicines	Dabu ying pills	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

Primary Outcome Measures

Name	Time	Method
Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months.	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).

Secondary Outcome Measures

Name	Time	Method
Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.	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).