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Open Access Research Article

Leuprolide Acetate 1-Month Depot for Central Precocious Puberty: Hormonal Suppression and Recovery

E Kirk Neely1*, Peter A Lee2*, Clifford A Bloch3, Lois Larsen4, Di Yang4, Cynthia Mattia-Goldberg4 and Kristof Chwalisz4

Author Affiliations

1 Division of Pediatric Endocrinology and Diabetes, Stanford University Medical Center, Room G313, Stanford, CA 94305-5208, USA

2 The Milton S. Hershey Medical Center, College of Medicine, Pennsylvania State University, Hershey, PA 17033, USA

3 Pediatric Endocrine Associates, 8200 E. Belleview, Suite 510-E, Greenwood Village, CO 80111, USA

4 Abbott Laboratories, 200 Abbott Park Road, Abbott Park, North Chicago, IL 60064, USA

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International Journal of Pediatric Endocrinology 2010, 2010:398639  doi:10.1155/2010/398639

Published: 19 January 2011

Abstract

Methods. This prospective US multicenter trial of leuprolide acetate 1-month depot (7.5–15 mg) for central precocious puberty utilized an open-label treatment period, long-term follow-up, and adult callback. Forty-nine females <9 years old with Tanner breast stage ≥2 before 8 years and 6 males <10 years old with Tanner genital stage ≥2 before 9 years with stimulated LH ≥10 IU/L and bone age advance ≥1 year were enrolled. Results. Subjects were treated for years. Mean peak GnRH-stimulated LH and FSH were prepubertal after the first dose and remained suppressed throughout treatment. During treatment, mean estradiol decreased to the limit of detection and mean testosterone decreased but remained above prepubertal norms. During posttreatment follow-up ( years), all patients achieved a pubertal hormonal response within 1 year and menses were reported in all females ≥12 years old. No impairment of reproductive function was observed at adulthood (mean age: 24.8 years).