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COMPLETEDPHASE3

A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.

NCT05029622•Ipsen

View on ClinicalTrials.gov

Summary

The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).

Eligibility

Age

0 - 10 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant is less than 9 years old for girls and less than 10 years old for boys at initiation of triptorelin treatment or at the time of signing the informed consent.
•Participant must present evidence of CPP documented by:
•Onset of development of secondary sex characteristics (breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II) before the age of 8 years in girls and 9 years in boys.
•Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥6 IU/L) in both sexes.
•Difference between bone age (BA) and CA \>1 year.
•Girls with Tanner staging ≥2 for breast development and who have enlarged uterine length and/or ovarian volume and at last 2 follicles with diameter \>4 mm in the ovary observed by pelvic type B ultrasound at the Screening visit; boys who have testicular volume ≥4 mL observed by testicular orchidometer at the Screening visit.
•Girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before the first dose of study intervention and should not be at risk of pregnancy throughout the study period.

Exclusion Criteria

•Gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
•Non-progressing isolated premature thelarche.
•Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
•Prior or current therapy with a GnRHa (Gonadotropin-releasing Hormone Agonist) , medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (IGF 1).Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.

Locations (14)

Beijing Children's Hospital, Capital Medical University

Beijing, China

No.1 Hospital of Jilin University (Bethune first hospital of Jilin University)

Changchun, China

Children's Hospital of Fudan University

Changhai, China

Hunan children's hospital

Changsha, China

Chengdu Women's & Children's Central Hospital

Chengdu, China

Shandong Provincial Hospital

Jinan, China

Linyi Maternal and Child Health Care Hospital

Linyi, China

Jiangxi Provincial Children's Hospital

Nanchang, China

Pingxiang Maternity and Child Care

Pingxiang, China

Children's Hospital of Soochow University

Suzhou, China

Key Dates

Start Date

August 10, 2021

Primary Completion Date

August 21, 2022

Completion Date

February 13, 2023

Last Updated

February 19, 2025

Enrollment

ACTUAL participants

Conditions

Central Precocious Puberty

Interventions

Triptorelin Pamoate

DRUG

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

NCT06129539

Central Precocious Puberty

View study

COMPLETED

Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

NCT06720623

Central Precocious Puberty (CPP)

View study

NOT_YET_RECRUITINGPHASE4

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

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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