Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.

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

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: Leuprolide; Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;

• Tanner stages of breast in female patients ≥ Tanner III stage，diameter of mammillary nucleus ≥ 3cm;

• B-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;

• Bone age: compared the chronological age, the bone age is more than 1 year and the bone age <11.5 years old;

• It progresses rapidly, ratio of bone age difference to chronological age difference> 1;

• No GnRH analogs or sex hormones were administrated in the past;

• All above are needed at the same time.

Exclusion Criteria:

• Precocious precocity caused by the central nervous system organic diseases;

• Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;

• Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;

• Pseudo sexual precocity and partial precocious puberty.