{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T05:40:34Z","timestamp":1791351634605,"version":"4.3.1"},"reference-count":47,"publisher":"The Endocrine Society","issue":"10","license":[{"start":{"date-parts":[[2020,8,1]],"date-time":"2020-08-01T00:00:00Z","timestamp":1596240000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Tolmar Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Gonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Determine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>Phase 3 multicenter, open-label, single-arm study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Setting<\/jats:title>\n                  <jats:p>25 sites in 6 countries.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Subjects<\/jats:title>\n                  <jats:p>64 GnRHa-na\u00efve children with CPP (age: 7.5 \u00b1 0.1 years) received study drug: 59 completed the study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Intervention(s)<\/jats:title>\n                  <jats:p>2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Main Outcome Measure(s)<\/jats:title>\n                  <jats:p>Percentage of children with serum luteinizing hormone (LH) &amp;lt;4 IU\/L 30 minutes following GnRHa stimulation at week 24.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>54\/62 (87%) children achieved poststimulation LH &amp;lt;4 IU\/L at week 24; 49\/56 (88%) girls and 1\/2 boys maintained peak LH &amp;lt;4 IU\/L at week 48. Mean growth velocity decreased from 8.9 cm\/year at week 4 to 6.0 cm\/year at week 48. Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48. Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys. Adverse events were mild and did not cause treatment discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgaa479","type":"journal-article","created":{"date-parts":[[2020,8,1]],"date-time":"2020-08-01T12:07:06Z","timestamp":1596283626000},"page":"e3660-e3671","source":"Crossref","is-referenced-by-count":34,"title":["Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty"],"prefix":"10.1210","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7953-4691","authenticated-orcid":false,"given":"Karen O","family":"Klein","sequence":"first","affiliation":[{"name":"Rady Children\u2019s Hospital and University of California, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anal\u00eda","family":"Freire","sequence":"additional","affiliation":[{"name":"Centro de Investigaciones Endocrinol\u00f3gicas \u201cDr. C\u00e9sar Bergad\u00e1\u201d (CEDIE) CONICET \u2013 FEI \u2013 Divisi\u00f3n de Endocrinolog\u00eda, Hospital de Ni\u00f1os Ricardo Gutierrez, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirta Graciela","family":"Gryngarten","sequence":"additional","affiliation":[{"name":"Centro de Investigaciones Endocrinol\u00f3gicas \u201cDr. C\u00e9sar Bergad\u00e1\u201d (CEDIE) CONICET \u2013 FEI \u2013 Divisi\u00f3n de Endocrinolog\u00eda, Hospital de Ni\u00f1os Ricardo Gutierrez, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gad B","family":"Kletter","sequence":"additional","affiliation":[{"name":"MultiCare Institute for Research and Innovation, Tacoma, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Benson","sequence":"additional","affiliation":[{"name":"Nemours Children\u2019s Hospital, Orlando, Florida"},{"name":"Nemours Children\u2019s Health System, Jacksonville, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley S","family":"Miller","sequence":"additional","affiliation":[{"name":"University of Minnesota Masonic Children\u2019s Hospital, Minneapolis, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tala S","family":"Dajani","sequence":"additional","affiliation":[{"name":"School of Osteopathic Medicine in Arizona, A.T. 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