Long-term continuous suppression with once-yearly histrelin subcutaneous implants for the treatment of central precocious puberty: A final report of a phase 3 multicenter trial

Journal of Clinical Endocrinology and Metabolism

Volumn 100, Issue 6, 2015, Pages 2354-2363

  Silverman, Lawrence A ^a   Neely, E Kirk ^b   Kletter, Gad B ^c   Lewis, Katherine ^d   Chitra, Surya ^e   Terleckyj, Oksana ^e   Eugster, Erica A ^f  

^a Atlantic Health   (United States)

^b STANFORD UNIVERSITY   (United States)

^c and Medical Genetics ^*  (United States)

^d MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^e ENDO PHARMACEUTICALS INC   (United States)

^f INDIANA UNIVERSITY HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GONADORELIN DERIVATIVE; HISTRELIN; LEUPRORELIN; DRUG IMPLANT; GONADORELIN;

ABSENCE OF SIDE EFFECTS; AGE; ARTICLE; BODY HEIGHT; BONE AGE; CHILD; CHILD GROWTH; CLINICAL ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG IMPLANT; DRUG TOLERABILITY; FEMALE; HUMAN; HYPOTHALAMUS HYPOPHYSIS GONAD SYSTEM; LONG TERM CARE; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRECOCIOUS PUBERTY; PRIORITY JOURNAL; PROSPECTIVE STUDY; SINGLE DRUG DOSE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DOWN REGULATION; DRUG ADMINISTRATION; DRUG EFFECTS; GONAD; HYPOTHALAMUS HYPOPHYSIS SYSTEM; PRESCHOOL CHILD; PUBERTY; PUBERTY, PRECOCIOUS; SUBCUTANEOUS DRUG ADMINISTRATION; TIME;

BODY HEIGHT; CHILD; CHILD, PRESCHOOL; DOWN-REGULATION; DRUG ADMINISTRATION SCHEDULE; DRUG IMPLANTS; FEMALE; GONADOTROPIN-RELEASING HORMONE; GONADS; HUMANS; HYPOTHALAMO-HYPOPHYSEAL SYSTEM; INJECTIONS, SUBCUTANEOUS; MALE; PUBERTY; PUBERTY, PRECOCIOUS; TIME FACTORS;

EID: 84930813914     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2014-3031     Document Type: Article

References (37)

1. Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123:e752-e762.
2. Downing J, Bellis MA. Early pubertal onset and its relationship with sexual risk taking, substance use and anti-social behaviour: a preliminary cross-sectional study. BMC Public Health. 2009;9:446.
3. Blumenthal H, Leen-Feldner EW, Babson KA, Gahr JL, Trainor CD, Frala JL. Elevated social anxiety among early maturing girls. Dev Psychol. 2011;47:1133-1140.
4. Mul D, Versluis-den Bieman HJ, Slijper FM, Oostdijk W, Waelkens JJ, Drop SL. Psychological assessments before and after treatment of early puberty in adopted children. Acta Paediatr. 2001;90:965-971.
5. Xhrouet-Heinrichs D, Lagrou K, Heinrichs C, et al. Longitudinal study of behavioral and affective patterns in girls with central precocious puberty during long-acting triptorelin therapy. Acta Paediatr. 1997;86:808-815.
6. Partsch CJ, Sippell WG. Treatment of central precocious puberty. Best Pract Res Clin Endocrinol Metab. 2002;16:165-189.
7. Mul D, Hughes IA. The use of GnRH agonists in precocious puberty. Eur J Endocrinol. 2008;159(suppl1):S3-S8.
8. Carel JC, Lahlou N, Jaramillo O, et al. Treatment of central precocious puberty by subcutaneous injections of leuprorelin 3-month depot (11.25 mg). J Clin Endocrinol Metab. 2002;87:4111-4116.
9. Manasco PK, Pescovitz OH, Blizzard RM. Local reactions to depot leuprolide therapy for central precocious puberty. J Pediatr. 1993;123:334-335.
10. Neely EK, Hintz RL, Parker B, et al. Two-year results of treatment with depot leuprolide acetate for central precocious puberty. J Pediatr. 1992;121:634-640.
11. Lewis KA, Eugster EA. Experience with the once-yearly histrelin (GnRHa) subcutaneous implant in the treatment of central precocious puberty. Drug Des Devel Ther. 2009;3:1-5.
12. Hirsch HJ, Gillis D, Strich D, et al. The histrelin implant: a novel treatment for central precocious puberty. Pediatrics. 2005;116:e798-e802.
13. Eugster EA, Clarke W, Kletter GB, et al. Efficacy and safety of histrelin subdermal implant in children with central precocious puberty: a multicenter trial. J Clin Endocrinol Metab. 2007;92:1697-1704.
14. Rahhal S, Clarke WL, Kletter GB, et al. Results of a second year of therapy with the 12-month histrelin implant for the treatment of central precocious puberty. Int J Pediatr Endocrinol. 2009;2009:812517.
15. Fuqua JS. Treatment and outcomes of precocious puberty: an update. J Clin Endocrinol Metab. 2013;98:2198-2207.
16. Lewis KA, Goldyn AK, West KW, Eugster EA. A single histrelin implant is effective for 2 years for treatment of central precocious puberty. J Pediatr. 2013;163:1214-1216.
17. Carel JC, Leger J. Clinical practice. Precocious puberty. N Engl J Med. 2008;358:2366-2377.
18. Neely EK, Lee PA, Bloch CA, et al. Leuprolide acetate 1-month depot for central precocious puberty: hormonal suppression and recovery. Int J Pediatr Endocrinol. 2010;2010:398639.
19. Clemons RD, Kappy MS, Stuart TE, Perelman AH, Hoekstra FT. Long-term effectiveness of depot gonadotropin-releasing hormone analogue in the treatment of children with central precocious puberty. Am J Dis Child. 1993;147:653-657.
20. Lee PA, Neely EK, Fuqua J, et al. Efficacy of leuprolide acetate 1-month depot for central precocious puberty (CPP): growth outcomes during a prospective, longitudinal study. Int J Pediatr Endocrinol. 2011;2011:7.
21. Tanaka T, Niimi H, Matsuo N, et al. Results of long-term follow-up after treatment of central precocious puberty with leuprorelin acetate: evaluation of effectiveness of treatment and recovery of gonadal function. The TAP-144-SR Japanese Study Group on Central Precocious Puberty. J Clin Endocrinol Metab. 2005;90:1371-1376.
22. Fuld K, Chi C, Neely EK. A randomized trial of 1- and 3-month depot leuprolide doses in the treatment of central precocious puberty. J Pediatr. 2011;159:982-987.e981.
23. Liang Y, Wei H, Zhang J, Hou L, Luo X. Efficacy of subcutaneous administration of gonadotropin-releasing hormone agonist on idiopathic central precocious puberty. J Huazhong Univ Sci Technolog Med Sci. 2006;26:558-561.
24. Pucarelli I, Segni M, Ortore M, Arcadi E, Pasquino AM. Effects of combined gonadotropin-releasing hormone agonist and growth hormone therapy on adult height in precocious puberty: a further contribution. J Pediatr Endocrinol Metab. 2003;16:1005-1010.
25. Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014;99:3153-3159.
26. Hirsch HJ, Lahlou N, Gillis D, et al. Free α-subunit is the most sensitive marker of gonadotropin recovery after treatment of central precocious puberty with the histrelin implant. J Clin Endocrinol Metab. 2010;95:2841-2844.
27. Gillis D, Karavani G, Hirsch HJ, Strich D. Time to menarche and final height after histrelin implant treatment for central precocious puberty. J Pediatr. 2013;163:532-536.
28. Fisher MM, Lemay D, Eugster EA. Resumption of puberty in girls and boys following removal of the histrelin implant. J Pediatr. 2014; 164:912-916 e911.
29. Roche AF, Chumlea WC, Thissen D. Assessing the Skeletal Maturity of the Hand Wrist: Fels Method. Springfield, IL: Charles C. Thomas Publishing Ltd; 1988.
30. National Center for Health Statistics. 2000 CDC growth charts: United States. http://www.cdc.gov/growthcharts. Accessed December 11, 2014.
31. Children's Hospital. Growth Calculator, version 2.01, Children's Hospital, Boston, MA. http://growthcalc.chip.org. Accessed December 11, 2014.
32. Neely EK, Silverman LA, Geffner ME, Danoff TM, Gould E, Thornton PS. Random unstimulated pediatric luteinizing hormone levels are not reliable in the assessment of pubertal suppression during histrelin implant therapy. Int J Pediatr Endocrinol. 2013;2013:20.
33. Lewis KA, Eugster EA. Random luteinizing hormone often remains pubertal in children treated with the histrelin implant for central precocious puberty. J Pediatr. 2013;162:562-565.
34. Lee PA, Klein K, Mauras N, et al. Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty. J Clin Endocrinol Metab. 2012;97:1572-1580.
35. Lee SJ, Yang EM, Seo JY, Kim CJ. Effects of gonadotropin-releasing hormone agonist therapy on body mass index and height in girls with central precocious puberty. Chonnam Med J. 2012;48:27-31.
36. Carel JC, Lahlou N, Roger M, Chaussain JL. Precocious puberty and statural growth. Hum Reprod Update. 2004;10:135-147.
37. Poomthavorn P, Suphasit R, Mahachoklertwattana P. Adult height, body mass index and time of menarche of girls with idiopathic central precocious puberty after gonadotropin-releasing hormone analogue treatment. Gynecol Endocrinol. 2011;27:524-528.