{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T18:42:18Z","timestamp":1782931338073,"version":"3.54.5"},"reference-count":58,"publisher":"Walter de Gruyter GmbH","issue":"0","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2016,1,17]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Triptorelin is an established treatment for central precocious puberty (CPP) as 1- and 3-month formulations. The current triptorelin 22.5 mg 6-month formulation is approved for prostate cancer therapy. This is the first study in patients with CPP.<\/jats:p><jats:p>The efficacy and safety of the triptorelin 6-month formulation in CPP were investigated. The primary objective was to evaluate the efficacy in achieving luteinizing hormone (LH) suppression to pre-pubertal levels at month 6. This was an international, non-comparative phase III study over 48 weeks. Eighteen medical centers in the US, Chile and Mexico participated. Forty-four treatment na\u00efve patients (39 girls and five boys) aged at treatment start 2\u20138 years for girls and 2\u20139 years for boys with an advancement of bone age over chronological age \u22651 year were to be included. Triptorelin was administered im twice at an interval of 24 weeks. LH, follicle stimulating hormone (FSH) (basal and stimulated), estradiol (girls), testosterone (boys), auxological parameters, clinical signs of puberty and safety were assessed.<\/jats:p><jats:p>Forty-one patients (93.2%) showed pre-pubertal LH levels (stimulated LH \u22645 IU\/L) at month 6 and maintained LH suppression through month 12. The percentage of patients with LH suppression exceeded 93% at each time point and reached 97.7% at month 12. No unexpected drug-related adverse events were reported.<\/jats:p><jats:p>The triptorelin 6-month formulation was safe and effective in suppressing the pituitary-gonadal axis in children with CPP. The extended injection interval may improve compliance and increase comfort in the management of CPP.<\/jats:p>","DOI":"10.1515\/jpem-2015-0376","type":"journal-article","created":{"date-parts":[[2016,2,17]],"date-time":"2016-02-17T14:05:33Z","timestamp":1455717933000},"source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty"],"prefix":"10.1515","volume":"0","author":[{"given":"Karen","family":"Klein","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Aisenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Wright","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Kaplowitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Najiba","family":"Lahlou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeannete","family":"Linares","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eija","family":"Lundstr\u00f6m","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Purcea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Cassorla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","reference":[{"key":"ref411","first-page":"963","article-title":"Treatment of central precocious puberty with triptorelin 11.25 mg depot formulation","volume":"19","year":"2006","journal-title":"J Pediatr Endocrinol Metab"},{"key":"ref481","first-page":"1322","volume-title":"Diagnostics of endocrine function in children and adolescents","year":"1997"},{"key":"ref291","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","year":"2009","journal-title":"Pediatrics"},{"key":"ref541","doi-asserted-by":"crossref","first-page":"1206","DOI":"10.1016\/j.clinbiochem.2012.05.019","article-title":"Reference intervals for reproductive hormones in prepubertal children on the automated Roche cobas e 411 analyzer","volume":"45","year":"2012","journal-title":"Clin Biochem"},{"key":"ref271","doi-asserted-by":"crossref","first-page":"2104","DOI":"10.1210\/jc.2013-4455","article-title":"Age-based reference ranges for annual height velocity in US children","volume":"99","year":"2014","journal-title":"J Clin Endocrin Metab"},{"key":"ref01","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","year":"2009","journal-title":"Pediatrics"},{"key":"ref51","first-page":"271","article-title":"Treatment of central precocious puberty with an LHRH analog. 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French study group of Decapeptyl in Precocious Puberty","volume":"84","year":"1999","journal-title":"J Clin Endocrinol Metab"},{"key":"ref231","first-page":"297","article-title":"Central precocious puberty: short-term comparative data of treatment with monthly or long-acting three months depot triptorelin","volume":"20","year":"2007","journal-title":"J Pediatr Endocrinol Metab"},{"key":"ref441","doi-asserted-by":"crossref","first-page":"1697","DOI":"10.1210\/jc.2006-2479","article-title":"Efficacy and safety of histrelin subdermal implant in children with central precocious puberty: a multicenter trial","volume":"92","year":"2007","journal-title":"J Clin Endocrinol Metab"},{"key":"ref461","volume-title":"Radiographic atlas of skeletal development of the hand and wrist","year":"1959"},{"key":"ref31","doi-asserted-by":"crossref","first-page":"1546","DOI":"10.1056\/NEJM198112243052602","article-title":"Short-term treatment of idiopathic precocious puberty with a long-acting analogue of luteinizing hormone-releasing hormone. A preliminary report","volume":"305","year":"1981","journal-title":"N Engl J Med"},{"key":"ref371","first-page":"723","article-title":"Pharmacokinetics and pharmacodynamics of GnRH agonists: clinical implications in pediatrics","volume":"13","year":"2000","journal-title":"J Pediatr Endocrinol Metab"},{"key":"ref201","first-page":"30","article-title":"Use of leuprolide acetate response patterns in the early diagnosis of pubertal disorders: comparison with the gonadotropin-releasing hormone test","volume":"78","year":"1994","journal-title":"J Clin Endocrinol Metab"},{"key":"ref451","volume-title":"Growth at adolescence","year":"1962"},{"key":"ref161","volume-title":"Growth at adolescence","year":"1962"},{"key":"ref321","doi-asserted-by":"crossref","first-page":"1546","DOI":"10.1056\/NEJM198112243052602","article-title":"Short-term treatment of idiopathic precocious puberty with a long-acting analogue of luteinizing hormone-releasing hormone. A preliminary report","volume":"305","year":"1981","journal-title":"N Engl J Med"},{"key":"ref241","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1111\/j.1365-2265.2010.03796.x","article-title":"Leuprolide stimulation testing for the evaluation of early female sexual maturation","volume":"73","year":"2010","journal-title":"Clin Endocrinol (Oxf)"},{"key":"ref141","doi-asserted-by":"crossref","first-page":"1572","DOI":"10.1210\/jc.2011-2704","article-title":"Efficacy and safety of leuprolide acetate 2-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty","volume":"97","year":"2012","journal-title":"J Clin Endocrinol Metab"},{"key":"ref341","first-page":"271","article-title":"Treatment of central precocious puberty with an LHRH analog. Effect on growth and bone maturation after 2 years of treatment","volume":"44","year":"1987","journal-title":"Arch Fr Pediatr"},{"key":"ref91","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1530\/eje.1.02056","article-title":"Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty","volume":"154","year":"2006","journal-title":"Eur J Endocrinol"},{"key":"ref401","doi-asserted-by":"crossref","first-page":"3483","DOI":"10.1210\/jc.2007-0321","article-title":"Growth pattern and final height after cessation of gonadotropin-suppressive therapy in girls with central sexual precocity","volume":"92","year":"2007","journal-title":"J Clin Endocrinol Metab"},{"key":"ref181","first-page":"1","article-title":"2000 CDC growth charts for the United States: Methods and development. National Center for Health Statistics","volume":"246","year":"2002","journal-title":"Vital Health Stat"},{"key":"ref221","first-page":"851","article-title":"The relationship between luteinizing hormone and estradiol secretion in female precocious puberty: evaluation by sensitive gonadotropin assays and the leuprolide stimulation test","volume":"76","year":"1993","journal-title":"J Clin Endocrinol Metab"},{"key":"ref311","doi-asserted-by":"crossref","first-page":"211","DOI":"10.2165\/00148581-200406040-00002","article-title":"Central precocious puberty: current treatment options","volume":"6","year":"2004","journal-title":"Paediatr Drugs"},{"key":"ref131","doi-asserted-by":"crossref","first-page":"757","DOI":"10.2165\/11319690-000000000-00000","article-title":"Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study","volume":"29","year":"2009","journal-title":"Clin Drug Investig"},{"key":"ref151","doi-asserted-by":"crossref","first-page":"1697","DOI":"10.1210\/jc.2006-2479","article-title":"Efficacy and safety of histrelin subdermal implant in children with central precocious puberty: a multicenter trial","volume":"92","year":"2007","journal-title":"J Clin Endocrinol Metab"},{"key":"ref361","first-page":"695","article-title":"Etiology and age incidence of precocious puberty in girls: a multicentric study","volume":"13","year":"2000","journal-title":"J Pediatr Endocrinol Metab"},{"key":"ref281","doi-asserted-by":"crossref","first-page":"191","DOI":"10.6065\/apem.2013.18.4.191","article-title":"The difference in serum alkaline phosphatase levels between girls with precocious puberty and those with normal puberty","volume":"18","year":"2013","journal-title":"Ann Pediatr Endocrinol Metab"},{"key":"ref431","doi-asserted-by":"crossref","first-page":"1572","DOI":"10.1210\/jc.2011-2704","article-title":"Efficacy and safety of leuprolide acetate 2-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty","volume":"97","year":"2012","journal-title":"J Clin Endocrinol Metab"},{"key":"ref521","first-page":"297","article-title":"Central precocious puberty: short-term comparative data of treatment with monthly or long-acting three months depot triptorelin","volume":"20","year":"2007","journal-title":"J Pediatr Endocrinol Metab"}],"container-title":["Journal of Pediatric Endocrinology and Metabolism"],"original-title":[],"link":[{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/jpem-2015-0376\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,22]],"date-time":"2021-04-22T01:40:04Z","timestamp":1619055604000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/jpem-2015-0376\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,1,17]]},"references-count":58,"journal-issue":{"issue":"0"},"URL":"https:\/\/doi.org\/10.1515\/jpem-2015-0376","relation":{},"ISSN":["2191-0251","0334-018X"],"issn-type":[{"value":"2191-0251","type":"electronic"},{"value":"0334-018X","type":"print"}],"subject":[],"published":{"date-parts":[[2016,1,17]]}}}