Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Weste… (NCT03963752) | Clinical Trial Compass
CompletedPhase 4
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
China126 participantsStarted 2019-08-15
Plain-language 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.
Who can participate
Age range5 Years – 8 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
Timeframe: After six months of continuous treatment