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Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

Primary Purpose

Central Precocious Puberty

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Triptorlin or Leuprorelin
Zhibo dihuang pills
Dabu ying pills
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Precocious Puberty focused on measuring epidemiology, treatment, molecular pathological mechanism, environmental disrupting chemicals

Eligibility Criteria

2 Years - 14 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    GnRHa(Triptorlin or Leuprorelin)

    Traditional Chinese Medicines

    blank group

    Arm Description

    Triptorlin or Leuprelin 100ug/kg per 28 days

    Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months

    without therapy

    Outcomes

    Primary Outcome Measures

    Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 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 Outcome Measures

    Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 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).

    Full Information

    First Posted
    August 16, 2016
    Last Updated
    September 28, 2016
    Sponsor
    Ruijin Hospital
    Collaborators
    Shanghai Children's Hospital, Shanghai Children's Medical Center, Xin Hua Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02920515
    Brief Title
    Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty
    Official Title
    Multi-site Study of Comprehensive Treatment for Children Precocious Puberty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruijin Hospital
    Collaborators
    Shanghai Children's Hospital, Shanghai Children's Medical Center, Xin Hua Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Precocious Puberty
    Keywords
    epidemiology, treatment, molecular pathological mechanism, environmental disrupting chemicals

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    740 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GnRHa(Triptorlin or Leuprorelin)
    Arm Type
    Experimental
    Arm Description
    Triptorlin or Leuprelin 100ug/kg per 28 days
    Arm Title
    Traditional Chinese Medicines
    Arm Type
    Active Comparator
    Arm Description
    Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months
    Arm Title
    blank group
    Arm Type
    No Intervention
    Arm Description
    without therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Triptorlin or Leuprorelin
    Other Intervention Name(s)
    Triptorlin, Leuprorelin
    Intervention Description
    Gonadotrophin releasing hormone agonists (GnRHa)
    Intervention Type
    Drug
    Intervention Name(s)
    Zhibo dihuang pills
    Intervention Description
    Traditional Chinese Medicine
    Intervention Type
    Drug
    Intervention Name(s)
    Dabu ying pills
    Intervention Description
    Traditional Chinese Medicine
    Primary Outcome Measure Information:
    Title
    Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months.
    Description
    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).
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.
    Description
    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).
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Comparisons of the BA/CA ratio'changes between GnRHa group and traditional chinese medicines group in 6 months.
    Description
    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).
    Time Frame
    6 months
    Title
    Comparisons of the sex hormone'changes between GnRHa group and traditional chinese medicines group in 6 months.
    Description
    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).
    Time Frame
    6 months
    Title
    Comparisons of the uterine volume'changes between GnRHa group and traditional chinese medicines group in 6 months.
    Description
    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).
    Time Frame
    6 months
    Title
    Comparisons of the ovarian volume'changes between GnRHa group and traditional chinese medicines group in 6 months.
    Description
    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).
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pin Li, Dr
    Organizational Affiliation
    Shanghai Children's Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xuefan Gu, Dr
    Organizational Affiliation
    Xin Hua Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xiaodong Huang, Dr
    Organizational Affiliation
    Shanghai children's medicial Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fan Jiang, Dr
    Organizational Affiliation
    Shanghai children's medicial Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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