Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

Central Precocious Puberty Clinical Trial

Official title:

Multi-site Study of Comprehensive Treatment for Children Precocious Puberty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920515
• Other study ID #: 12411950400
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2016
• Last updated: September 28, 2016
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 2 Years to 14 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Triptorlin or Leuprorelin
Gonadotrophin releasing hormone agonists (GnRHa)
• Zhibo dihuang pills
Traditional Chinese Medicine
• Dabu ying pills
Traditional Chinese Medicine

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Children's Hospital, Shanghai Children's Medical Center, Xin Hua Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	6 months	No
Other	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).	6 months	No
Other	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).	6 months	No
Other	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).	6 months	No
Primary	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	No
Secondary	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).	6 months	No