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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

NCTNCT06487143 (opens ClinicalTrials.gov in a new tab)Other id3-month TP vs 1-month TP

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
134 participants (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

China

Start
1 Jul 2024 (estimated)
Primary completion
30 Dec 2026 (estimated)
Completion
30 Dec 2026 (estimated)
First posted
5 Jul 2024
Last update posted
5 Jul 2024
Conditions
Central Precocious Puberty

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 4

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

    NCT06487143

    est. 1 Jul 2024 to est. 30 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin pamoate(15mg)Drug
  • Triptorelin acetate (3.75mg)Drug

Arms2

  • Experimental

    3-month triptorelin

    Triptorelin pamoate is administered via intramuscular injection once every three months

  • Active comparator

    1-month triptorelin

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The proportion of LH of ≤ 3 IU/L

    Time frame · 3 months after injection of 3-month TP and 1-month TP

    Registry description

    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.

Secondary outcomes(11)
  1. Basal LH( IU/L),Basal FSH(IU/L), Estradiol (female) (pg/mL)and testosterone (male)(pg/mL)

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

    Registry description

    Changes in baseline luteinizing hormone (LH) levels ,follicle-stimulating hormone (FSH), estradiol (E2), and testosterone (T) after treatment compared to baseline.Serum LH, FSH, estradiol and testosterone levels were measured by electroimmunochemiluminescence assays.

  2. Tanner stage

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

    Registry description

    Percentage of children with regression or no progression in Tanner staging. Pubertal stage was determined by an experienced pediatric endocrinologist according to the method proposed by Marshall and Tanner.

  3. Uterine length (female)(mL) and testicular volume (male)(mL)

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

    Registry description

    Changes in uterine length and ovarian volume for girls, and testicular volume for boys. Pelvic ultrasound will be used to measure the uterine length and ovarian dimensions (length, width, and thickness). The ovarian volume will be calculated using the given formula.The Prader orchidometer will be used to measure the testicular volume before and after treatment.

  4. Growth velocity (cm/y)

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

    Registry description

    Changes in growth velocity (GV) after treatment compared to baseline.Growth velocity (GV) is typically measured as the annual growth rate, which is the increase in height over a year.

  5. BA/CA

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

    Registry description

    Changes in bone age (BA) and the ratio of bone age to chronological age (BA/CA) compared to baseline. Bone age determination will be conducted using an X-ray imaging device to capture X-ray images of the hand and wrist. The BA will be interpreted using a standardized AI bone age assessment instrument (Yitu system).

  6. PAH(cm)

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

    Registry description

    Predicted adult height (PAH) was calculated using the average tables from the Bayley-Pinneau method

  7. Body composition

    Time frame · Month 0 and 12 after injection of triptorelin 3M and 1M

    Registry description

    Comparison of body fat percentage after treatment to baseline using Dual-Energy X-ray Absorptiometry (DXA).

  8. Bone Mineral Density

    Time frame · Month 0 and 12 after injection of triptorelin 3M and 1M

    Registry description

    Comparison of the lowest T-score among the lumbar spine (L1-L4), total hip, and femoral neck after treatment to baseline using Dual-Energy X-ray Absorptiometry (DXA).

  9. BMISDS

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

    Registry description

    Standard deviation scores (SDS) of body mass index (BMI) were calculated using the 2005 growth chart for Chinese children and adolescents aged 0-18 years.Changes in BMI SDS after Treatment Compared to Baseline

  10. glucose metabolism

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

    Registry description

    Changes in Fasting Blood Glucose(mmol/L), Fasting Insulin(μU/mL), and HOMA-IR After Treatment Compared to Baseline.HOMA-IR was calculated by (Fasting Insulin(μU/mL)×Fasting Glucose(mmol/L)) minus 22.5.

  11. lipid metabolism

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

    Registry description

    Changes in Total Cholesterol (TC)(mg/dL) , Low-Density Lipoprotein (LDL) (mg/dL) ,High-Density Lipoprotein (HDL)(mg/dL), Triglycerides (TG) (mg/dL)After Treatment Compared to Baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Observational study · 2021

4 results

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.

Chung et al. 2021Journal of Korean medical sciencecited by 21

PMID 34463062PMC8405405DOI 10.3346/jkms.2021.36.e219PUB-34463062

Free to read · publisher termsCC BY-NC4 results

Indexing hint: Clinical trial · 2006

10 results

Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty.

Carel et al. 2006European journal of endocrinologycited by 43

PMID 16382000DOI 10.1530/eje.1.02056PUB-16382000

Rights unknown10 results

More studies

2 studies on this page

PubMed tag: none · 2023

Efficacy and Safety of Triptorelin 3-Month Formulation in Chinese Children with Central Precocious Puberty: A Phase 3, Open-Label, Single-Arm Study.

Luo et al. 2023Advances in therapycited by 6

PMID 37584898PMC10499740DOI 10.1007/s12325-023-02617-8PUB-37584898

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Meta-analysis (pooled) · 2017

Meta-Analysis of Paediatric Patients with Central Precocious Puberty Treated with Intramuscular Triptorelin 11.25 mg 3-Month Prolonged-Release Formulation
.

Durand et al. 2017Hormone research in paediatricscited by 19

PMID 28334719DOI 10.1159/000456545PUB-28334719

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultSubspecialty 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
  • ResultCheuiche 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
  • ResultBangalore 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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. 2. 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). 3. GnRH stimulation test: LH peak value ≥ 5 IU/L (chemiluminescence method), with an LH peak/FSH peak ratio ≥ 0.6. 4. Bone age (BA) exceeds chronological age (CA) by 1 year or more (based on bone age assessment during the screening period at this center). 5. Accelerated linear growth, with an annual growth rate higher than that of healthy children of the same age. 6. No prior treatment with gonadotropin-releasing hormone agonists. 7. Body weight of at least 20 kg. Exclusion Criteria: 1.Target Diseases: 1. 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.). 2. 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. 2.Treatment History, Medical History, and Concomitant Medical Conditions: 3. Known hypersensitivity to any investigational substance or related compounds. 4. Any chronic disease or treatment deemed by the investigator to potentially interfere with growth or other study endpoints \[including but not limited to: long-term glucocorticoid use (excluding short-term topical use), renal failure, diabetes, moderate to severe scoliosis\]. 5. 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). 6. 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. 7. BMI ≥ 95th percentile (same age and gender).

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