{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T16:20:10Z","timestamp":1776270010664,"version":"3.50.1"},"reference-count":30,"publisher":"The Endocrine Society","issue":"7","license":[{"start":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T00:00:00Z","timestamp":1685577600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie, Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,6,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Treatment options for central precocious puberty (CPP) are important for individualization of therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>We evaluated the efficacy and safety of 6-month 45-mg leuprolide acetate (LA) depot with intramuscular administration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>LA depot was administered at weeks 0 and 24 to treatment-na\u00efve (n = 27) or previously treated (n = 18) children with CPP in a phase 3, multicenter, single-arm, open-label study (NCT03695237). Week 24 peak-stimulated luteinizing hormone (LH) suppression (&amp;lt;4\u2005mIU\/mL) was the primary outcome. Secondary\/other outcomes included basal sex hormone suppression (girls, estradiol &amp;lt;20\u2005pg\/mL; boys, testosterone &amp;lt;30\u2005ng\/dL), suppression of physical signs, height velocity, bone age, patient\/parent-reported outcomes, and adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>All patients (age, 7.8 \u00b1 1.27 years) received both scheduled study doses. At 24 weeks, 39\/45 patients (86.7%) had LH suppressed. Six were counted as unsuppressed; 2 because of missing data, 3 with LH of 4.35\u22125.30\u2005mIU\/mL and 1 with LH of 21.07\u2005mIU\/mL. Through 48 weeks, LH, estradiol, and testosterone suppression was achieved in \u226586.7%, \u226597.4%, and 100%, respectively (as early as week 4 for LH and estradiol and week 12 for testosterone). Physical signs were suppressed at week 48 (girls, 90.2%; boys, 75.0%). Mean height velocity ranged 5.0 to 5.3\u2005cm\/year post-baseline in previously treated patients and declined from 10.1 to 6.5\u2005cm\/year at week 20 in treatment-na\u00efve patients. Mean bone age advanced slower than chronological age. Patient\/parent-reported outcomes remained stable. No new safety signals were identified. No adverse event led to treatment discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Six-month intramuscular LA depot demonstrated 48-week efficacy with a safety profile consistent with other GnRH agonist formulations.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/jendso\/bvad071","type":"journal-article","created":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T17:57:18Z","timestamp":1685642238000},"source":"Crossref","is-referenced-by-count":7,"title":["Efficacy and Safety of Leuprolide Acetate 6-Month Depot for the Treatment of Central Precocious Puberty: A Phase 3 Study"],"prefix":"10.1210","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7953-4691","authenticated-orcid":false,"given":"Karen O","family":"Klein","sequence":"first","affiliation":[{"name":"University of California, San Diego, and Rady Children's Hospital San Diego , San Diego, CA 92121 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1175-3852","authenticated-orcid":false,"given":"Nelly","family":"Mauras","sequence":"additional","affiliation":[{"name":"Nemours Children's Health , Jacksonville, FL 32207 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunil","family":"Nayak","sequence":"additional","affiliation":[{"name":"Pediatric Endocrine Associates , Greenwood Village, CO 80111 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bhuvana","family":"Sunil","sequence":"additional","affiliation":[{"name":"Mary Bridge Children's Hospital , Tacoma, WA 98403 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Blanca M","family":"Martinez-Placencia","sequence":"additional","affiliation":[{"name":"AbbVie, Inc. , North Chicago, IL 60064 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanja","family":"Dragnic","sequence":"additional","affiliation":[{"name":"AbbVie, Inc. , North Chicago, IL 60064 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mayra","family":"Ballina","sequence":"additional","affiliation":[{"name":"AbbVie, Inc. , North Chicago, IL 60064 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qing","family":"Zhou","sequence":"additional","affiliation":[{"name":"AbbVie, Inc. , North Chicago, IL 60064 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0811-622X","authenticated-orcid":false,"given":"Alvina R","family":"Kansra","sequence":"additional","affiliation":[{"name":"AbbVie, Inc. , North Chicago, IL 60064 , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"80","published-online":{"date-parts":[[2023,6,1]]},"reference":[{"issue":"5","key":"2023061614060661300_bvad071-B1","doi-asserted-by":"crossref","first-page":"965","DOI":"10.1210\/js.2019-00036","article-title":"Treatment of central precocious puberty","volume":"3","author":"Eugster","year":"2019","journal-title":"J Endocr Soc"},{"issue":"4","key":"2023061614060661300_bvad071-B2","doi-asserted-by":"crossref","first-page":"e752","DOI":"10.1542\/peds.2008-1783","article-title":"Consensus statement on the use of gonadotropin-releasing hormone analogs in children","volume":"123","author":"Carel","year":"2009","journal-title":"Pediatrics"},{"issue":"suppl_1","key":"2023061614060661300_bvad071-B3","doi-asserted-by":"crossref","first-page":"S3","DOI":"10.1530\/EJE-08-0814","article-title":"The use of GnRH agonists in precocious puberty","volume":"159","author":"Mul","year":"2008","journal-title":"Eur J 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