A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
NCT ID: NCT05029622
Last Updated: 2025-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
66 participants
INTERVENTIONAL
2021-08-10
2023-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Triptorelin formulation for Intramuscular injection (IM).
Triptorelin Pamoate
Triptorelin 6-month formulation for IM on day 1 and Month 6.
Interventions
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Triptorelin Pamoate
Triptorelin 6-month formulation for IM on day 1 and Month 6.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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
Wuhan Children's Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, , China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, , China
Wuxi children's Hospital
Wuxi, , China
Zhengzhou Children's Hospital , Henan Children's Hospital
Zhengzhou, , China
Countries
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References
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Yu X, Cheng X, Wei H, Xu X, Gong C, Li G, Yao H, Zhou L, Zhong Y, Yang Y, Luo F, Zhang Y, Huang F, Shi X, Cabri P, Luo X. A Phase 3, Open-Label, Single-Arm Trial of the Efficacy and Safety of Triptorelin 6-Month Formulation in Chinese Children with Central Precocious Puberty. Adv Ther. 2024 Dec;41(12):4537-4556. doi: 10.1007/s12325-024-02991-x. Epub 2024 Oct 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2022-003857-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-CN-52014-244
Identifier Type: -
Identifier Source: org_study_id
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