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Completed

NCT Number: NCT02920515

Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

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.

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Key information

Age range

2 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation.
  • Accelerated linear growth: the annual growth rate is higher than normal.
  • Advanced bone age: the bone age is 1 or years more than the actual age
  • 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;
  • HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values.
  • Subjects should be willing and able to follow the study protocol during the study period.
  • 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

  • Patients with central nervous system diseases and thyroid diseases;
  • Patients with CHA-induced precocious puberty;
  • Patients with poor compliance.

Treatment and study plan

Triptorlin or Leuprorelin

Drug

Gonadotrophin releasing hormone agonists (GnRHa)

Other names: Triptorlin, Leuprorelin

Zhibo dihuang pills

Drug

Traditional Chinese Medicine

Dabu ying pills

Drug

Traditional Chinese Medicine

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Other outcomes

  1. Comparisons of the BA/CA ratio'changes between GnRHa group and traditional chinese medicines group in 6 months.

    Time frame: 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).

  2. Comparisons of the sex hormone'changes between GnRHa group and traditional chinese medicines group in 6 months.

    Time frame: 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).

  3. Comparisons of the uterine volume'changes between GnRHa group and traditional chinese medicines group in 6 months.

    Time frame: 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).

  4. Comparisons of the ovarian volume'changes between GnRHa group and traditional chinese medicines group in 6 months.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai Children's Hospital
  • Shanghai Children's Medical Center
  • Xin Hua Hospital of Zhejiang Province

Registry information

Official study title

Multi-site Study of Comprehensive Treatment for Children Precocious Puberty

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2016
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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