Central Precocious PubertyPhase 4NCT02920515
Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty
A Phase 4 study testing Triptorlin or Leuprorelin, Zhibo dihuang pills and Dabu ying pills in people with Central Precocious Puberty, run by Ruijin Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 2 to 14 years, women only
- Conditions the study is for
- Central Precocious Puberty
- What is being tested?
- Triptorlin or Leuprorelin, Zhibo dihuang pills and Dabu ying pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patients with central nervous system diseases and thyroid diseases;
- Patients with CHA-induced precocious puberty;
- Patients with poor compliance.
About this study
Official title: 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.
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
- Central Precocious Puberty
- Being tested
- Triptorlin or Leuprorelin, Zhibo dihuang pills, Dabu ying pills
- Keywords
- epidemiology, treatment, molecular pathological mechanism, environmental disrupting chemicals
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorlin or LeuprorelinDrug
Also called Triptorlin, Leuprorelin
Gonadotrophin releasing hormone agonists (GnRHa)
Zhibo dihuang pillsDrug
Traditional Chinese Medicine
Dabu ying pillsDrug
Traditional Chinese Medicine
| Study group | Role | What they receive |
|---|---|---|
| GnRHa(Triptorlin or Leuprorelin) | Experimental | Triptorlin or Leuprelin 100ug/kg per 28 days Receives: 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 Receives: Drug: Zhibo dihuang pills; Drug: Dabu ying pills |
| blank group | No intervention | without therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xin Hua Hospital of Zhejiang Province
- Responsible party
- Principal investigator, WeiWang, Ruijin Hospital
- Investigators
- Pin Li, Dr, Principal investigator, Shanghai Children's HospitalXuefan Gu, Dr, Principal investigator, Xin Hua Hospital of Zhejiang ProvinceXiaodong Huang, Dr, Principal investigator, Shanghai children's medicial CenterFan Jiang, Dr, Principal investigator, Shanghai children's medicial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920515
- Sponsor's protocol ID
- 12411950400
- Status last verified
- Sep 2016
- First submitted
- 16 Aug 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Study of Comprehensive Treatment for Children Precocious Puberty
- ClinicalTrials.gov ID
- NCT02920515
- Acronym / sponsor ID
- 12411950400
- Conditions
- Central Precocious Puberty
- Keywords
- epidemiology, treatment, molecular pathological mechanism, environmental disrupting chemicals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xin Hua Hospital of Zhejiang Province
- Study start
- Sep 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GnRHa(Triptorlin or Leuprorelin) | Experimental | Drug: Triptorlin or LeuprorelinTriptorlin or Leuprelin 100ug/kg per 28 days |
| Traditional Chinese Medicines | Active comparator | Drug: Zhibo dihuang pills, Drug: Dabu ying pillsZhibo 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 |
| blank group | No intervention | –without therapy |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with central nervous system diseases and thyroid diseases;
- Patients with CHA-induced precocious puberty;
- Patients with poor compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorlin or LeuprorelinAlso: Triptorlin, LeuprorelinGonadotrophin releasing hormone agonists (GnRHa) | Drug | GnRHa(Triptorlin or Leuprorelin) |
| Zhibo dihuang pillsTraditional Chinese Medicine | Drug | Traditional Chinese Medicines |
| Dabu ying pillsTraditional Chinese Medicine | Drug | Traditional Chinese Medicines |
Primary outcome
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).
1 secondary outcome
Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: Yes
Related trials for Central Precocious Puberty
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Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptorlin or Leuprorelin, Zhibo dihuang pills and Dabu ying pills in people with Central Precocious Puberty, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.