Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP

NCT06487143 | Not Yet Recruiting Phase 4

• 1 other identifier: 3-month TP vs 1-month TP
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the efficacy of the 3-month formulation and 1-month formulation of triptorelin and to assess the short-term effects of the 3-month formulation of triptorelin on glucose and lipid metabolism, body composition, and bone density in Chinese ICPP patients.

Conditions

Central Precocious Puberty

Keywords

Central Precocious Puberty; GnRHa; predicted adult height; metabolism; bone mineral density

Outcome Measures

Primary Outcomes (1)

• The proportion of LH of ≤ 3 IU/L

  In the GnRHa stimulation test, triptorelin is administered intravenously at a dose of 0.1 mg/m² (with a maximum dose of 0.1 mg). Blood samples are collected 60 minutes after administration to measure luteinizing hormone (LH) levels.Serum LH levels were measured by electroimmunochemiluminescence assays.

  3 months after injection of 3-month TP and 1-month TP

Secondary Outcomes (11)

• Basal LH（ IU/L),Basal FSH（IU/L), Estradiol (female) (pg/mL)and testosterone (male)(pg/mL)

  Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M

• Tanner stage

  Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M

• Uterine length (female)（mL) and testicular volume (male)(mL)

  Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M

• Growth velocity (cm/y)

  Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M

• BA/CA

  Month 0, 6 and 12 after injection of triptorelin 3M and 1M

Study Arms (2)

3-month triptorelin

EXPERIMENTAL

Triptorelin pamoate is administered via intramuscular injection once every three months

Drug: Triptorelin pamoate（15mg）

1-month triptorelin

ACTIVE COMPARATOR

Triptorelin acetate 3.75mg is administered via intramuscular injection once every four weeks.

Drug: Triptorelin acetate （3.75mg）

Interventions

Triptorelin pamoate（15mg） DRUG

Triptorelin pamoate 15mg is administered via intramuscular injection once every three months.

3-month triptorelin

Triptorelin acetate （3.75mg） DRUG

Triptorelin acetate 3.75mg is administered via intramuscular injection once every four weeks.

1-month triptorelin

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Early appearance of secondary sexual characteristics, specifically breast development in girls before 8 years old or menarche before 10 years old, and testicular enlargement in boys before 9 years old.
• Gonadal enlargement: pelvic ultrasound shows that girls have at least one ovarian follicle with a diameter \>4mm, and breast development is at least at Tanner stage II; boys have a testicular volume ≥ 4 ml (measured with Prader orchidometer).
• GnRH stimulation test: LH peak value ≥ 5 IU/L (chemiluminescence method), with an LH peak/FSH peak ratio ≥ 0.6.
• Bone age (BA) exceeds chronological age (CA) by 1 year or more (based on bone age assessment during the screening period at this center).
• Accelerated linear growth, with an annual growth rate higher than that of healthy children of the same age.
• No prior treatment with gonadotropin-releasing hormone agonists.
• Body weight of at least 20 kg.

You may not qualify if:

• Target Diseases:
• Secondary central precocious puberty: This includes central nervous system abnormalities (tumors or space-occupying lesions, acquired injuries, congenital developmental abnormalities, etc.) and other diseases (congenital adrenal hyperplasia, familial male-limited precocious puberty, McCune-Albright syndrome, etc.).
• Slow-progressing central precocious puberty: Some children show signs of sexual development before the defined age (7-8 years), but the progression of sexual development and bone age is slow, and linear growth remains within the corresponding percentiles.
• Treatment History, Medical History, and Concomitant Medical Conditions:
• Known hypersensitivity to any investigational substance or related compounds.
• Any chronic disease or treatment deemed by the investigator to potentially interfere with growth or other study endpoints \[including but not limited to: long-term glucocorticoid use (excluding short-term topical use), renal failure, diabetes, moderate to severe scoliosis\].
• Girls with a bone age over 12.5 years or menarche ≥ 1 year; boys with a bone age over 14 years (based on bone age assessment during the screening period at this center).
• Congenital long QT syndrome/12-lead ECG at screening showing QTc ≥ 500 ms corrected by Bazett's formula, excluding other factors causing prolonged QT interval on ECG/12-lead ECG at screening showing QTc between 480 and 499 ms accompanied by unexplained syncope, with no other factors causing prolonged QT interval and no pathogenic mutations.
• BMI ≥ 95th percentile (same age and gender).

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510020, China

Location

Related Publications (9)

• Subspecialty Group of Endocrinologic, Hereditary and Metabolic Diseases, the Society of Pediatrics, Chinese Medical Association; Editorial Board, Chinese Journal of Pediatrics. [Expert consensus on the diagnosis and treatment of central precocious puberty(2022)]. Zhonghua Er Ke Za Zhi. 2023 Jan 2;61(1):16-22. doi: 10.3760/cma.j.cn112140-20220802-00693. Chinese.

  PMID: 36594116 RESULT

• Cheuiche AV, da Silveira LG, de Paula LCP, Lucena IRS, Silveiro SP. Diagnosis and management of precocious sexual maturation: an updated review. Eur J Pediatr. 2021 Oct;180(10):3073-3087. doi: 10.1007/s00431-021-04022-1. Epub 2021 Mar 21.

  PMID: 33745030 RESULT

• Luo X, Zhang C, Yang Y, Xu X, Cheng X, Wei H, Wang L, Huang F, Shi X, Cabri P. Efficacy and Safety of Triptorelin 3-Month Formulation in Chinese Children with Central Precocious Puberty: A Phase 3, Open-Label, Single-Arm Study. Adv Ther. 2023 Oct;40(10):4574-4588. doi: 10.1007/s12325-023-02617-8. Epub 2023 Aug 16.

  PMID: 37584898 RESULT

• Bangalore Krishna K, Fuqua JS, Rogol AD, Klein KO, Popovic J, Houk CP, Charmandari E, Lee PA, Freire AV, Ropelato MG, Yazid Jalaludin M, Mbogo J, Kanaka-Gantenbein C, Luo X, Eugster EA, Klein KO, Vogiatzi MG, Reifschneider K, Bamba V, Garcia Rudaz C, Kaplowitz P, Backeljauw P, Allen DB, Palmert MR, Harrington J, Guerra-Junior G, Stanley T, Torres Tamayo M, Miranda Lora AL, Bajpai A, Silverman LA, Miller BS, Dayal A, Horikawa R, Oberfield S, Rogol AD, Tajima T, Popovic J, Witchel SF, Rosenthal SM, Finlayson C, Hannema SE, Castilla-Peon MF, Mericq V, Medina Bravo PG. Use of Gonadotropin-Releasing Hormone Analogs in Children: Update by an International Consortium. Horm Res Paediatr. 2019;91(6):357-372. doi: 10.1159/000501336. Epub 2019 Jul 18.

  PMID: 31319416 RESULT

• Durand A, Tauber M, Patel B, Dutailly P. Meta-Analysis of Paediatric Patients with Central Precocious Puberty Treated with Intramuscular Triptorelin 11.25 mg 3-Month Prolonged-Release Formulation . Horm Res Paediatr. 2017;87(4):224-232. doi: 10.1159/000456545. Epub 2017 Mar 23.

  PMID: 28334719 RESULT

• Chung LY, Kang E, Nam HK, Rhie YJ, Lee KH. Efficacy of Triptorelin 3-Month Depot Compared to 1-Month Depot for the Treatment of Korean Girls with Central Precocious Puberty in Single Tertiary Center. J Korean Med Sci. 2021 Aug 30;36(34):e219. doi: 10.3346/jkms.2021.36.e219.

  PMID: 34463062 RESULT

• Carel JC, Blumberg J, Seymour C, Adamsbaum C, Lahlou N; Triptorelin 3-month CPP Study Group. Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty. Eur J Endocrinol. 2006 Jan;154(1):119-24. doi: 10.1530/eje.1.02056.

  PMID: 16382000 RESULT

• Huang S, Zhang L, Gao C, Ou H, Hou L, Liu Z, Wang D, Xu Y, Liang L, Meng Z. Efficacy and safety of leuprorelin 3-month depot (11.25 mg) for idiopathic central precocious puberty treatment of Chinese girls: a single-center retrospective study. J Pediatr Endocrinol Metab. 2023 Nov 20;37(1):15-20. doi: 10.1515/jpem-2023-0410. Print 2024 Jan 29.

  PMID: 37975727 RESULT

• Ramos CO, Canton APM, Seraphim CE, Faria AG, Tinano FR, Mendonca BB, Latronico AC, Brito VN. Anthropometric, metabolic, and reproductive outcomes of patients with central precocious puberty treated with leuprorelin acetate 3-month depot (11.25 mg). J Pediatr Endocrinol Metab. 2021 Jul 23;34(11):1371-1377. doi: 10.1515/jpem-2021-0142. Print 2021 Nov 25.

  PMID: 34298591 RESULT

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Zhe Meng, master

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

• Liyang Liang, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siqi Huang, master

CONTACT

+8615692418384; huangsq23@mail.sysu.edu.cn

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: Associate chief physician

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)