Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP (NCT06487143) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP
China134 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range2 Years – 10 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕.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.
What they're measuring
1
The proportion of LH of ≤ 3 IU/L
Timeframe: 3 months after injection of 3-month TP and 1-month TP
Trial details
NCT IDNCT06487143
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
✕.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.