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.

Tanaka, Toshiaki; Hibi, Itsuro; Kato, Kiyohiko; Saito, S; Shimizu, Nobuko; Suwa, Seizo; Nakajima, Hideto

doi:10.1507/endocrj1954.38.369

Cited by 45 publications

(29 citation statements)

References 17 publications

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“…Inadequate dosage could be responsible for ineffective suppression. However, in all children the mean dose per month exceeded the minimally needed dose (30 µg/kg) as calculated by Tanaka et al [27]. In another study [7], it was also shown that in most children a dose of 3.75 mg resulted in a dose per kilogram that was largely above this minimally required dose.…”

Section: Discussionmentioning

confidence: 68%

Auxological and Biochemical Evaluation of Pubertal Suppression with the GnRH Agonist Leuprolide Acetate in Early and Precocious Puberty

et al. 1999

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We studied the auxological effects of treatment with the GnRH agonist leuprolide acetate (Lucrin^®) at 3.75 mg/ 28 days in 38 children with early or precocious puberty. We present our newly developed scoring system, the Puberty Suppression Score (PSS), in which clinical and biochemical parameters determine whether suppression was effective. Leuprolide acetate suppressed pubertal development in the majority of cases. During treatment there was a significant correlation between the number of times that PSS was >0 and gain in predicted adult height (PAH) compared to initial prediction at the start of treatment. After 6 months of treatment, ineffective suppression measured by PSS was associated with the magnitude of gain in PAH. We conclude that a leuprolide acetate dosage of 3.75 mg every 28 days effectively suppresses puberty. PSS is helpful in monitoring the suppressive capacity of a GnRH agonist. We recommend to start with leuprolide acetate at 3.75 mg/28 days and to increase the injection frequency or dose in case PSS is >0 after 6 months of treatment.

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Section: Discussionmentioning

confidence: 68%

Auxological and Biochemical Evaluation of Pubertal Suppression with the GnRH Agonist Leuprolide Acetate in Early and Precocious Puberty

et al. 1999

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“…The dose at the last visit was 100 µg/kg/month. These doses are well above the dose of 90 µg/kg/month recommended for leuprorelin in Europe and Japan [4, 5, 22]; however, they are considerably below the dose of 300 µg/kg/month recommended in the US [20, 23]. Since to date no difference in long-term results between the European and the US CPP patients have been demonstrated, we believe that the European dose is sufficient in the majority of patients.…”

Section: Discussionmentioning

confidence: 93%

Long-Term Suppression of Pituitary-Gonadal Function with Three-Month Depot of Leuprorelin Acetate in a Girl with Central Precocious Puberty

Schroeter¹,

Baus²,

Sippell³

et al. 2002

Horm Res Paediatr

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Objective: The efficacy of a 3-month depot preparation of the GnRH agonist leuprorelin acetate in central precocious puberty was studied. Methods: Treatment with a 3-month depot of leuprorelin acetate was performed subcutaneously in a 7.3-year-old girl with central precocious puberty. Results: During treatment the hormonal suppression was constant and complete as demonstrated by suppressed GnRH stimulation tests and prepubertal estradiol plasma levels. The size and volume of the uterus and ovaries returned to the normal range. The rate of bone maturation was significantly reduced with a ratio ΔBA/ΔCA of 0.58 for 3 treatment years. Thus, the effects of treatment were comparable to those reported for treatment with 1-month depot of GnRH agonists. Conclusion: Three-month depots have the advantage of a prolonged injection interval which is more convenient for the patients and reduces costs by necessitating fewer visits to the physician and being approximately 10% cheaper than the 1-month depot. We suggest that comparative and randomized studies be performed to make 3-month depots of GnRH agonists available for routine use in children with central precocious puberty.

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“…The dose needed to adequately suppress puberty varies considerably. 8,15 Inadequate therapy can lead to clinical progression and continued advancement of bone maturation. 8,9 On the other hand, excessive dosing is costly: recent pharmacy retail pricing at our hospital shows that a 3.75-mg dose of depot leuprolide costs a patient $643, 7.5 mg costs $855, and 11.25 mg costs $1598.…”

Section: Discussionmentioning

confidence: 99%

Serum Luteinizing Hormone Rises Within Minutes After Depot Leuprolide Injection: Implications for Monitoring Therapy

2002

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ABSTRACT. Objective. To find the time of the serum gonadotropin peak after depot leuprolide injection in children and to show that depot leuprolide therapy can be monitored by measuring serum luteinizing hormone (LH) immediately after injections.Study Design. We measured concentrations of leuprolide, LH, and follicle-stimulating hormone (FSH) at multiple time points before and after the first dose of depot leuprolide in 14 pubertal children beginning therapy. Gonadotropins and sex steroids were measured again after the fourth dose.Results. Serum leuprolide, LH, and FSH levels rose rapidly after initial injection, reaching sustained elevations at 30 to 120 minutes. The median LH level increased from 2.1 mIU/mL at baseline to a peak of 27.5 mIU/mL at 45 minutes, and FSH increased from 5.2 to 16.5 mIU/mL. After 3 months on therapy, median serum LH after depot leuprolide injection was only 0.83 mIU/mL, similar to levels observed after intravenous or subcutaneous gonadotropin-releasing hormone stimulation in comparable subjects on depot leuprolide.Conclusion. Our pharmacokinetic data demonstrate that free leuprolide present in a depot leuprolide injection is equivalent to gonadotropin-releasing hormone in stimulating a rapid rise in serum gonadotropin concentrations. We propose that a single serum sample for LH obtained 30 to 60 minutes after depot leuprolide injection in children provides a convenient and accurate assessment of treatment efficacy. Pediatrics 2002;109(2). URL: http://www.pediatrics.org/cgi/content/full/109/2/e30; puberty, leuprolide, luteinizing hormone, follicle-stimulating hormone, gonadotropin, gonadotropin-releasing hormone.ABBREVIATIONS. CPP, central precocious puberty; GnRH, gonadotropin-releasing hormone; LH, luteinizing hormone; FSH, follicle-stimulating hormone; IM, intramuscular; IV, intravenous; SQ, subcutaneous. C entral precocious puberty (CPP) is the early onset of pubertal development attributable to premature gonadotropin release by the pituitary. Most commonly idiopathic, CPP can also result from central nervous system trauma or tumors. Untreated, precocious puberty can result in short stature and significant social problems for children undergoing sexual maturation years before their peers. 1,2 Pulsatile secretion of endogenous gonadotropin-releasing hormone (GnRH) results in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) release from the pituitary and progression of puberty, 3 whereas the tonic stimulus of a long-acting GnRH analog causes an initial surge of gonadotropin release, followed by suppression of pituitary gonadotropin production and release. 4,5 Depot leuprolide (Depot-Lupron, TAP Pharmaceuticals, Deerfield, IL), a commonly used long-acting GnRH analog, is given by monthly intramuscular (IM) injection and is slowly released into the circulation to provide such tonic suppressive levels.Depot leuprolide consists of leuprolide encased in microspheres of a glycolic and lactic acid copolymer. Free leuprolide is also present in the preparation 6 and is absorbe...

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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.

Cited by 45 publications

References 17 publications

Auxological and Biochemical Evaluation of Pubertal Suppression with the GnRH Agonist Leuprolide Acetate in Early and Precocious Puberty

Auxological and Biochemical Evaluation of Pubertal Suppression with the GnRH Agonist Leuprolide Acetate in Early and Precocious Puberty

Long-Term Suppression of Pituitary-Gonadal Function with Three-Month Depot of Leuprorelin Acetate in a Girl with Central Precocious Puberty

Serum Luteinizing Hormone Rises Within Minutes After Depot Leuprolide Injection: Implications for Monitoring Therapy

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