Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

September 28, 2016 updated by: WeiWang, Ruijin Hospital

Multi-site Study of Comprehensive 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

740

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Leuprorelin
  • Triptorlin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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).
6 months
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).
6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Shanghai Children's Hospital
Shanghai Children's Medical Center
Xin Hua Hospital

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (ESTIMATE)

September 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12411950400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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