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.

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.

• Authors: T Tanaka, I Hibi, K Kato, S Saito, N Shimizu, S Suwa, H Nakajima
• Journal: Endocrinologia japonica (Endocrinol Jpn) Vol. 38 Issue 4 Pg. 369-76 (Aug 1991) ISSN: 0013-7219 [Print] Japan
• PMID: 1839379 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article)

Chemical References

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

Topics

• 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)