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Efficacy and Safety of Histrelin Subdermal Implant in Children with Central Precocious Puberty: A Multicenter Trial

Riley Hospital for Children (E.A.E.), Indiana University School of Medicine, Indianapolis, Indiana 46202; University of Virginia (W.C.), Charlottesville, Virginia 22908; Seattle Childrens Hospital and Medical Center (G.B.K.), Seattle, Washington 98104; Pennsylvania State Children’s Hospital (P.A.L.), Hershey, Pennsylvania 17033; Stanford University Medical Center (E.K.N.), Stanford, California 94305; Baystate Children’s Hospital (E.O.R.), Springfield, Massachusetts 01199; Montefiore Medical Center (P.S.), Bronx, New York 10461; University of South Florida and All Children’s Hospital (D.S.), St. Petersburg, Florida 33701; Goryeb Children’s Hospital Atlantic Health System (L.S.), Morristown, New Jersey 07962; and Valera Pharmaceuticals (L.F., W.G., D.T.), Cranbury, New Jersey 08512

Address all correspondence and requests for reprints to: Erica A. Eugster, M.D., Pediatric Endocrinology, Riley Hospital for Children, Room 5960, 702 Barnhill Drive, Indianapolis, Indiana 46202. E-mail: eeugster{at}iupui.edu.

Context: GnRH analog (GnRHa) therapy for central precocious puberty (CPP) typically involves im injections. The histrelin implant is a new treatment that provides a continuous slow release of the GnRHa histrelin.

Objective: The objective of the study was to investigate the safety and efficacy of the subdermal histrelin implant for the treatment of CPP in treatment naive and previously treated children.

Design: This was a phase III, open-label, prospective study of 1-yr duration.

Setting: The study was conducted at nine U.S. medical centers.

Patients: Girls ages 2–8 yr (naive) or 2–10 yr (previously treated) and boys 2–9 yr (naive) or 2–11 yr (previously treated) with clinical evidence of CPP and a pretreatment pubertal response to leuprolide stimulation were eligible.

Intervention: A 50-mg histrelin implant was inserted sc in the inner upper arm.

Main Outcome Measures: Peak LH after GnRHa stimulation testing and estradiol (girls) and testosterone (boys) were the main outcome measures.

Results: Thirty-six subjects (20 naive) were enrolled. By 1 month, peak LH fell from 28.2 ± 19.97 (naive) to 0.8 ± 0.39 mIU/ml (P < 0.0001) and from 2.1 ± 2.15 (previously treated) to 0.5 ± 0.32 mIU/ml (P < 0.0056). Estradiol suppressed from 24.5 ± 22.27 (naive) to 5.9 ± 2.37 pg/ml (P = 0.0016) and remained suppressed in previously treated subjects, as did testosterone. Suppression was maintained throughout the study. No significant adverse events occurred.

Conclusions: The subdermal histrelin implant achieves and maintains excellent suppression of peak LH and sex steroid levels for 1 yr in children with CPP. The treatment is well tolerated. Long-term studies are needed to confirm these results.

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				D Mul and I A Hughes The use of GnRH agonists in precocious puberty Eur. J. Endocrinol., December 1, 2008; 159(suppl_1): S3 - S8. [Abstract] [Full Text] [PDF]