A dose finding study of a super long-acting luteinizing hormone-releasing hormone analog (leuprolide acetate depot, TAP-144-SR) in the treatment of central precocious puberty. The TAP-144-SR CPP Study Group

Endocrinol Jpn. 1991 Aug;38(4):369-76. doi: 10.1507/endocrj1954.38.369.

Abstract

The effect of leuprolide acetate (D-Leu6-[des-Gly10-NH2]-LH-RH ethylamide acetate) for depot suspension (TAP-144-SR), a synthetic analog of luteinizing hormone-releasing hormone, was examined in three doses in 36 patients (34 girls, 2 boys) with central precocious puberty. TAP-144-SR was injected subcutaneously every four weeks for twelve weeks, and clinical symptoms and plasma and urinary levels of various hormones were followed every four weeks. Eleven girls given 10 micrograms/kg showed a significant decrease in peak plasma LH and FSH responses to LH-RH test, but basal plasma LH and FSH did not change significantly. In 13 patients (11 girls and 2 boys) given 30 micrograms/kg and 12 girls given 90 micrograms/kg, both basal and peak LH and FSH were significantly suppressed. Urinary excretion of LH decreased significantly in all groups except in the 10 micrograms/kg group. Urinary excretion of FSH did not change significantly in the 10 and 30 micrograms/kg groups, but it decreased significantly in the 90 micrograms/kg group. In girls, plasma and urinary estradiol also fell greatly, but the difference was insignificant except in the 90 micrograms/kg group. Regression of sexual characteristics was observed in almost half of the patients at the 12th week of the treatment. Side effects were minimal. A dose of more than 30 micrograms/kg of TAP-144-SR is effective in suppressing gonadotropins and causing improvement of clinical symptoms, and appears to be useful in treating children with central precocious puberty.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • 17-Hydroxycorticosteroids / urine
  • 17-Ketosteroids / urine
  • Adrenal Glands / drug effects
  • Analysis of Variance
  • Child
  • Child, Preschool
  • Dehydroepiandrosterone / blood
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Estradiol / blood
  • Female
  • Follicle Stimulating Hormone / urine
  • Humans
  • Immunoradiometric Assay
  • Infant
  • Insulin-Like Growth Factor I / analysis
  • Leuprolide / pharmacology*
  • Luteinizing Hormone / urine
  • Male
  • Puberty, Precocious / drug therapy*
  • Testosterone / blood

Substances

  • 17-Hydroxycorticosteroids
  • 17-Ketosteroids
  • Delayed-Action Preparations
  • Testosterone
  • Dehydroepiandrosterone
  • Estradiol
  • Insulin-Like Growth Factor I
  • Luteinizing Hormone
  • Follicle Stimulating Hormone
  • Leuprolide