Central Precocious Puberty
Conditions
Keywords
epidemiology, treatment, molecular pathological mechanism, environmental disrupting chemicals
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.
Interventions
DRUGTriptorlin or Leuprorelin
Gonadotrophin releasing hormone agonists (GnRHa)
DRUGZhibo dihuang pills
Traditional Chinese Medicine
DRUGDabu ying pills
Traditional Chinese Medicine
Sponsors
Shanghai Children's Hospital
Shanghai Children's Medical Center
Xin Hua Hospital
Ruijin Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
2 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparisons of the BA/CA ratio'changes between GnRHa group and traditional chinese medicines group in 6 months. | 6 months | The change levels of BA/CA ratio in the GnRHa group (n=152) is lower than in the traditional chinese medicines group (n=86) ,(P\<0.05). |
| Comparisons of the sex hormone'changes between GnRHa group and traditional chinese medicines group in 6 months. | 6 months | The change levels of sex hormone(LH,FSH and E2) in the GnRHa group (n=164) is lower than in the traditional chinese medicines group (n=94) ,(P\<0.05). |
| Comparisons of the uterine volume'changes between GnRHa group and traditional chinese medicines group in 6 months. | 6 months | The change levels of uterine volume in the GnRHa group (n=157) is lower than in the traditional chinese medicines group (n=91) ,(P\<0.05). |
| Comparisons of the ovarian volume'changes between GnRHa group and traditional chinese medicines group in 6 months. | 6 months | The change levels of ovarian volume in the GnRHa group (n=152) is lower than in the traditional chinese medicines group (n=88) ,(P\<0.05). |
Outcome results
None listed