NCT02920515

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

August 16, 2016

Last Update Submit

September 28, 2016

Conditions

Central Precocious Puberty

Keywords

epidemiologytreatmentmolecular pathological mechanismenvironmental disrupting chemicals

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (1)

  • Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.

    6 months

Other Outcomes (4)

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

    6 months

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

    6 months

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

    6 months

  • +1 more other outcomes

Study Arms (3)

GnRHa(Triptorlin or Leuprorelin)

EXPERIMENTAL

Triptorlin or Leuprelin 100ug/kg per 28 days

Drug: Triptorlin or Leuprorelin

Traditional Chinese Medicines

ACTIVE COMPARATOR

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 pillsDrug: Dabu ying pills

blank group

NO INTERVENTION

without therapy

Interventions

Triptorlin or LeuprorelinDRUG

Gonadotrophin releasing hormone agonists (GnRHa)

Also known as: Triptorlin, Leuprorelin
GnRHa(Triptorlin or Leuprorelin)
Zhibo dihuang pillsDRUG

Traditional Chinese Medicine

Traditional Chinese Medicines
Dabu ying pillsDRUG

Traditional Chinese Medicine

Traditional Chinese Medicines

Eligibility Criteria

Age2 Years - 14 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 16, 2016

First Posted

September 30, 2016

Study Start

September 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share