Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty.

OBJECTIVE Depot GnRH agonists are commonly used in the treatment of central precocious puberty (CPP). The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP. DESIGN This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly. METHODS Children with a clinical onset of pubertal development before the age of 8 years (girls) or 9 years (boys), pubertal response of LH to GnRH > or = 7 IU/l, advanced bone age > 1 year, enlarged uterus (> or = 36 mm) and testosterone level > or = 0.5 ng/ml (boys), were included. Suppression of gonadotropic activation, as determined from serum LH, FSH, estradiol or testosterone, and pubertal signs were assessed at Months 3, 6 and 12. RESULTS GnRH-stimulated peak LH < or = 3 IU/l, the main efficacy criterion, was met in 53 out of 62 (85%), 60 out of 62 (97%) and 56 out of 59 (95%) of the children at Months 3, 6 and 12 respectively. Serum FSH and sex steroids were also significantly reduced, while pubertal development regressed in most patients. Mean residual triptorelin levels were stable from Month 3 through to Month 12. The triptorelin 3-month depot was well tolerated. Severe injection pain was experienced in only one instance. Five girls experienced mild-to-moderate or severe (one girl) withdrawal bleeding. CONCLUSIONS The triptorelin 3-month depot efficiently suppresses the pituitary-gonadal axis and pubertal development in children with CPP. This formulation allows a 3-fold reduction, over the once-a-month depot, in the number of i.m. injections required each year.

[1]  J. Carel,et al.  Precocious puberty and statural growth. , 2004, Human reproduction update.

[2]  A. Schindler,et al.  Equivalence of the 3-month and 28-day formulations of triptorelin with regard to achievement and maintenance of medical castration in women with endometriosis. , 2004, Fertility and sterility.

[3]  H. Pinedo.  The Role of VEGF in Oncology: Effects on Hemostasis and Thrombosis , 2003, Pathophysiology of Haemostasis and Thrombosis.

[4]  C. Teinturier,et al.  Treatment of central precocious puberty by subcutaneous injections of leuprorelin 3-month depot (11.25 mg). , 2002, The Journal of clinical endocrinology and metabolism.

[5]  V. Tillmann,et al.  Suppression of puberty with long‐acting goserelin (Zoladex‐LA): effect on gonadotrophin response to GnRH in the first treatment cycle , 2002, Clinical endocrinology.

[6]  W. Sippell,et al.  Treatment of central precocious puberty. , 2002, Best practice & research. Clinical endocrinology & metabolism.

[7]  J. Carel,et al.  Final height after long-term treatment with triptorelin slow release for central precocious puberty: importance of statural growth after interruption of treatment. French study group of Decapeptyl in Precocious Puberty. , 1999, The Journal of clinical endocrinology and metabolism.

[8]  D. Jacqmin,et al.  Three-Month Sustained-Release Form of Triptorelin in Patients with Advanced Prostatic Adenocarcinoma: Results of an Open Pharmacodynamic and Pharmacokinetic Multicenter Study , 1998, Hormone Research in Paediatrics.

[9]  J. Carel,et al.  Treatment of central precocious puberty with depot leuprorelin. French Leuprorelin Trial Group. , 1995, European journal of endocrinology.

[10]  S. Bernasconi,et al.  Final height in girls with central precocious puberty: comparison of two different luteinizing hormone‐releasing hormone agonist treatments , 1994, Acta paediatrica.

[11]  M. Craen,et al.  Variations in pituitary—gonadal suppression during intranasal buserelin and intramuscular depot‐triptorelin therapy for central precocious puberty , 1994, Acta paediatrica.

[12]  O. Pescovitz,et al.  Local reactions to depot leuprolide therapy for central precocious puberty. , 1993, The Journal of pediatrics.

[13]  R. Battini,et al.  Growth velocity and serum aminoterminal propeptide of type III procollagen in precocious puberty during gonadotropin‐releasing hormone analogue treatment , 1993, Acta paediatrica.

[14]  L. Bachrach,et al.  Two-year results of treatment with depot leuprolide acetate for central precocious puberty. , 1992, The Journal of pediatrics.

[15]  S. Rose,et al.  Acta Paediatrica Scandinavica , 1991, Archives of disease in childhood.

[16]  P. A. Lee,et al.  Depot leuprolide acetate dosage for sexual precocity. , 1991, The Journal of clinical endocrinology and metabolism.

[17]  W. Crowley,et al.  Gonadotropin-releasing hormone and its analogues. , 1991, The New England journal of medicine.

[18]  R. Odink,et al.  Treatment of children with central precocious puberty by a slow-release gonadotropin-releasing hormone agonist , 1990, European Journal of Pediatrics.

[19]  O. Pescovitz,et al.  Resumption of puberty after long term luteinizing hormone-releasing hormone agonist treatment of central precocious puberty. , 1988, The Journal of clinical endocrinology and metabolism.

[20]  J. Chaussain,et al.  Long term treatment of male and female precocious puberty by periodic administration of a long-acting preparation of D-Trp6-luteinizing hormone-releasing hormone microcapsules. , 1986, The Journal of clinical endocrinology and metabolism.

[21]  W. Crowley,et al.  Short-term treatment of idiopathic precocious puberty with a long-acting analogue of luteinizing hormone-releasing hormone. A preliminary report. , 1981, The New England journal of medicine.

[22]  W. Crowley,et al.  Therapeutic use of pituitary desensitization with a long-acting lhrh agonist: a potential new treatment for idiopathic precocious puberty. , 1981, The Journal of clinical endocrinology and metabolism.

[23]  M. Maresh,et al.  Radiographic Atlas of Skeletal Development of the Hand and Wrist , 1950 .

[24]  R. Odink,et al.  Comparison of complete and incomplete suppression of pituitary-gonadal activity in girls with central precocious puberty: influence on growth and predicted final height. The German-Dutch Precocious Puberty Study Group. , 1993, Hormone research.

[25]  R. Odink,et al.  Long-term results with a slow-release gonadotrophin-releasing hormone agonist in central precocious puberty. Dutch-German Precocious Puberty Study Group. , 1991, Acta paediatrica Scandinavica. Supplement.

[26]  R. Milsted,et al.  Gonadotropin-releasing hormone and its analogues. , 1991, The New England journal of medicine.

[27]  Z. Laron,et al.  Pubertal development, growth and final height in girls with sexual precocity after therapy with the GnRH analogue D-TRP-6-LHRH. A report on 15 girls, followed after cessation of gonadotrophin suppressive therapy. , 1990, Hormone research.