Chinese Medical Journal (Jan 2015)

Efficacy and Safety of Domestic Leuprorelin in Girls with Idiopathic Central Precocious Puberty: A Multicenter, Randomized, Parallel, Controlled Trial

  • Wen-Jing Li,
  • Chun-Xiu Gong,
  • Mei-Jie Guo,
  • Jie Xing,
  • Tang Li,
  • Wen-Hui Song,
  • Xiao-Ping Luo,
  • Di Wu,
  • Jian-Ping Liang,
  • Bing-Yan Cao,
  • Yi Gu,
  • Chang Su,
  • Xue-Jun Liang,
  • Min Liu,
  • Rui Wang,
  • Feng-Ting Li

DOI
https://doi.org/10.4103/0366-6999.156773
Journal volume & issue
Vol. 128, no. 10
pp. 1314 – 1320

Abstract

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Background: In central precocious puberty (CPP), the pulse secretion and release of gonadotropin-releasing hormone (GnRH) are increased due to early activation of the hypothalamic-pituitary-gonadal axis, resulting in developmental abnormalities with gonadal development and appearance of secondary sexual characteristics. The CPP without organic disease is known as idiopathic CPP (ICPP). The objective of the study was to evaluate the clinical efficacy and safety of domestic leuprorelin (GnRH analog) in girls with ICPP. Methods: A total of 236 girls with ICPP diagnosed from April 2012 to January 2014 were selected and were randomized into two groups. One hundred fifty-seven girls in the test group were treated with domestic leuprorelin acetate, 79 girls in the control group were treated with imported leuprorelin acetate. They all were treated and observed for 6 months. After 6-month treatment, the percentage of children with peak luteinizing hormone (LH) ≤3.3 U/L, the percentage of children with peak LH/peak follicle stimulating hormone (FSH) ratio 0.05). Conclusions: Domestic leuprorelin is effective and safe in the treatment of Chinese girls with ICPP. Its effectiveness and safety are comparable with imported leuprorelin.

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