Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Central Precocious Puberty

Treatments: Drug: Triptorlin or Leuprorelin; Drug: Dabu ying pills; Drug: Zhibo dihuang pills

Study type: Interventional

Funder types: Other

Identifiers

NCT02920515

12411950400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 740 patients

Sex: Female

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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740 participants in 3 patient groups

GnRHa(Triptorlin or Leuprorelin)

Experimental group

Description:

Triptorlin or Leuprelin 100ug/kg per 28 days

Treatment:

Drug: Triptorlin or Leuprorelin

Traditional Chinese Medicines

Active Comparator group

Description:

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

Treatment:

Drug: Zhibo dihuang pills

Drug: Dabu ying pills

blank group

No Intervention group

Description:

without therapy