Clinical trial NCT02920515: Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty
Official title: Multi-site Study of Comprehensive Treatment for Children Precocious Puberty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Precocious Puberty
Keywords: epidemiology
treatment
molecular pathological mechanism
environmental disrupting chemicals
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Shanghai Children's Medical Center
name: Xin Hua Hospital
First posted: 2016-09-30
Enrollment: 740
Sex: FEMALE
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.
timeFrame: 6 months
Other outcomes:
measure: Comparisons of the BA/CA ratio'changes between GnRHa group and traditional chinese medicines group in 6 months.
timeFrame: 6 months
measure: Comparisons of the sex hormone'changes between GnRHa group and traditional chinese medicines group in 6 months.
timeFrame: 6 months
measure: Comparisons of the uterine volume'changes between GnRHa group and traditional chinese medicines group in 6 months.
timeFrame: 6 months
measure: Comparisons of the ovarian volume'changes between GnRHa group and traditional chinese medicines group in 6 months.
timeFrame: 6 months
Locations:
Study officials:
affiliation: Shanghai Children's Hospital
name: Pin Li, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Xin Hua Hospital
name: Xuefan Gu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai children's medicial Center
name: Xiaodong Huang, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai children's medicial Center
name: Fan Jiang, Dr
role: PRINCIPAL_INVESTIGATOR
References: