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KMID : 0363420220360030001
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Journal of Korean Oriental Pediatrics
2022 Volume.36 No. 3 p.1 ~ p.18
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The Current State of Registration of Interventional Clinical Trials for Children and Adolescents with Precocious Puberty
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Shim Soo-Bo
Seo Hyun-Sik
Lee Hyun-Hee
Lee Hye-Lim
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Abstract
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Objectives : The purpose of this study was to investigate the current status of interventional clinical trial registration for
children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean
medicine treatment of precocious puberty.
Methods : The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International
Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search
terms, ‘Precocious puberty’, ‘child’. All clinical trials which were registered as of June 2022 were used.
Results : For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in
41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been
reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as
inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum
concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8%
of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were
also reported.
Conclusions : In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials
identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine
treatment of precocious puberty.
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KEYWORD
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Clinical trial, Interventional study, ICTRP, CRIS, Precocious puberty
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