Clinical Trial: Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-site Study of Comprehensive Treatment for Children Precocious Puberty

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 Summary: 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.
Sponsor: Ruijin Hospital

Current Primary Outcome: Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months. [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months. [ Time Frame: 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).


Original Secondary Outcome: Same as current

Information By: Ruijin Hospital

Dates:
Date Received: August 16, 2016
Date Started: September 2012
Date Completion:
Last Updated: September 28, 2016
Last Verified: September 2016