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Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

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ClinicalTrials.gov Identifier: NCT02920515
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Collaborators:
Shanghai Children's Hospital
Shanghai Children's Medical Center
Xin Hua Hospital
Information provided by (Responsible Party):
WeiWang, Ruijin Hospital

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.

Condition or disease Intervention/treatment Phase
Central Precocious Puberty Drug: Triptorlin or Leuprorelin Drug: Zhibo dihuang pills Drug: Dabu ying pills Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 740 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-site Study of Comprehensive Treatment for Children Precocious Puberty
Study Start Date : September 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: GnRHa(Triptorlin or Leuprorelin)
Triptorlin or Leuprelin 100ug/kg per 28 days
Drug: Triptorlin or Leuprorelin
Gonadotrophin releasing hormone agonists (GnRHa)
Other Names:
  • Triptorlin
  • Leuprorelin

Active Comparator: Traditional Chinese Medicines
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
Drug: Zhibo dihuang pills
Traditional Chinese Medicine

Drug: Dabu ying pills
Traditional Chinese Medicine

No Intervention: blank group
without therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920515


Sponsors and Collaborators
Ruijin Hospital
Shanghai Children's Hospital
Shanghai Children's Medical Center
Xin Hua Hospital
Investigators
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Principal Investigator: Pin Li, Dr Shanghai Children's Hospital
Principal Investigator: Xuefan Gu, Dr Xin Hua Hospital
Principal Investigator: Xiaodong Huang, Dr Shanghai children's medicial Center
Principal Investigator: Fan Jiang, Dr Shanghai children's medicial Center

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Responsible Party: WeiWang, professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02920515     History of Changes
Other Study ID Numbers: 12411950400
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by WeiWang, Ruijin Hospital:
epidemiology
treatment
molecular pathological mechanism
environmental disrupting chemicals
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases