Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Collaborators: Shanghai Children's Hospital; Shanghai Children's Medical Center; Xin Hua Hospital
• Treatments: Leuprolide

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.