CompletedNCT02920515Updated Sep 30, 2016

Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

A Phase 4 interventional study of Triptorlin or Leuprorelin and Zhibo dihuang pills in Central Precocious Puberty, sponsored by Ruijin Hospital. Completed. Open to female participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2016-09-30.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 740
Allocation: Non-randomized
Ages: 2 Years to 14 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Central Precocious Puberty

Browse trials for

Puberty, Precocious 77

Keywords

epidemiology
treatment
molecular pathological mechanism
environmental disrupting chemicals

In context

Puberty, Precocious

77 studies on the registry are indexed under Puberty, Precocious; 20 are open to participants now.

This study's enrollment of 740 is above the median of 64 across 49 interventional studies indexed under Puberty, Precocious.

Browse Puberty, Precocious studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 14 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 740 participants (actual)

Study arms

Experimental
GnRHa(Triptorlin or Leuprorelin)
Triptorlin or Leuprelin 100ug/kg per 28 days
Drug: Triptorlin or 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 · Drug: Dabu ying pills
No intervention
blank group
without therapy

Interventions

DrugTriptorlin or Leuprorelin
Gonadotrophin releasing hormone agonists (GnRHa)
Also known as: Triptorlin, Leuprorelin
DrugZhibo dihuang pills
Traditional Chinese Medicine
DrugDabu ying pills
Traditional Chinese Medicine

What researchers measure

Primary outcomes

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).
Time frame: 6 months

Secondary outcomes

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).
Time frame: 6 months

Other outcomes

Comparisons of the BA/CA ratio'changes between GnRHa group and traditional chinese medicines group in 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).
Time frame: 6 months
Comparisons of the sex hormone'changes between GnRHa group and traditional chinese medicines group in 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).
Time frame: 6 months
Comparisons of the uterine volume'changes between GnRHa group and traditional chinese medicines group in 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).
Time frame: 6 months
Comparisons of the ovarian volume'changes between GnRHa group and traditional chinese medicines group in 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).
Time frame: 6 months

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 16, 2016
First posted: Sep 30, 2016
Start: Sep 2012
Primary completionActual: Aug 2015
CompletionActual: Aug 2015
Last update: Sep 30, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02920515
Lead sponsor: Ruijin Hospital
Collaborators: Shanghai Children's Hospital, Shanghai Children's Medical Center, Xin Hua Hospital of Zhejiang Province
Responsible party: WeiWang (professor, Ruijin Hospital) — Principal investigator
First posted: Sep 30, 2016
Start date: Sep 2012
Primary completion: Aug 2015
Completion: Aug 2015
Last update: Sep 30, 2016

Study contacts

Pin Li, Dr

principal investigator · Shanghai Children's Hospital

Xuefan Gu, Dr

principal investigator · Xin Hua Hospital of Zhejiang Province

Xiaodong Huang, Dr

principal investigator · Shanghai children's medicial Center

Fan Jiang, Dr

principal investigator · Shanghai children's medicial Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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