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The project aims to establish the normal LH and FSH response to a standardized GnRH dose in healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH response in girls with early puberty development.
The novel data may help to determine whether the girl is in early puberty or not.
Healthy girls under 6 years of age attending routine examinations including an i.v. line for other causes are included in this study. Our examinations also include bone age determination, Tanner stage determination, and anthropometric measures (height and weight). 10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months and 60-72 months are included.
Please refer to the brief summary which covers the study aim, methods and outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH intervention | Experimental | All participating subjects are assigned to receive an intravenous GnRH agonist injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH agonist | Drug | 100 µg/m2 body surface max 100 µg i.v. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LH response | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| FSH response | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Up till age 6.0 years | |
| Height | Up till age 6.0 years | |
| Tanner-stage (breast and pubic hair) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels H. Birkebæk, MD PhD | Contact | +45 50860090 | nielbirk@rm.dk | |
| Mia E. Sømod, Stud. med | Contact | +45 60199810 | mia.elbek.somod@studmed.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Niels H. Birkebæk, MD PhD | Børneafdeling A, AUH, Skejby | Principal Investigator |
| Esben T. Vestergaard, MD PhD | Børneafdeling A, AUH, Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Børneafdelingen A, AUH, Skejby | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18509122 | Background | Carel JC, Leger J. Clinical practice. Precocious puberty. N Engl J Med. 2008 May 29;358(22):2366-77. doi: 10.1056/NEJMcp0800459. No abstract available. | |
| 16322154 | Background | Teilmann G, Pedersen CB, Jensen TK, Skakkebaek NE, Juul A. Prevalence and incidence of precocious pubertal development in Denmark: an epidemiologic study based on national registries. Pediatrics. 2005 Dec;116(6):1323-8. doi: 10.1542/peds.2005-0012. |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Up till age 6.0 years |
| Bone age | Up till age 6.0 years |
| Hormones (estrogen, inhibin B, SHBG, kisspeptin) | Up till age 6.0 years |
| Kurt Kristensen, MD PhD |
| Børneafdeling A, AUH, Skejby |
| Principal Investigator |
| Søren Rittig, MD DMSc | Børneafdeling A, AUH, Skejby | Principal Investigator |
| Kostas Kamperis, MD PhD | Børneafdeling A, AUH, Skejby | Principal Investigator |
| Mia E. Sømod, Stud.med | Børneafdelig A, AUH, Skejby | Principal Investigator |
| 9093289 | Background | Herman-Giddens ME, Slora EJ, Wasserman RC, Bourdony CJ, Bhapkar MV, Koch GG, Hasemeier CM. Secondary sexual characteristics and menses in young girls seen in office practice: a study from the Pediatric Research in Office Settings network. Pediatrics. 1997 Apr;99(4):505-12. doi: 10.1542/peds.99.4.505. |
| 19189683 | Background | Houk CP, Kunselman AR, Lee PA. The diagnostic value of a brief GnRH analogue stimulation test in girls with central precocious puberty: a single 30-minute post-stimulation LH sample is adequate. J Pediatr Endocrinol Metab. 2008 Dec;21(12):1113-8. doi: 10.1515/jpem.2008.21.12.1113. |
| 22099730 | Background | Curfman AL, Reljanovic SM, McNelis KM, Dong TT, Lewis SA, Jackson LW, Cromer BA. Premature thelarche in infants and toddlers: prevalence, natural history and environmental determinants. J Pediatr Adolesc Gynecol. 2011 Dec;24(6):338-41. doi: 10.1016/j.jpag.2011.01.003. |
| 21854448 | Background | Atay Z, Turan S, Guran T, Furman A, Bereket A. The prevalence and risk factors of premature thelarche and pubarche in 4- to 8-year-old girls. Acta Paediatr. 2012 Feb;101(2):e71-5. doi: 10.1111/j.1651-2227.2011.02444.x. Epub 2011 Sep 23. |
| 19914634 | Background | de Vries L, Guz-Mark A, Lazar L, Reches A, Phillip M. Premature thelarche: age at presentation affects clinical course but not clinical characteristics or risk to progress to precocious puberty. J Pediatr. 2010 Mar;156(3):466-71. doi: 10.1016/j.jpeds.2009.09.071. Epub 2009 Nov 14. |
| 17284632 | Background | Resende EA, Lara BH, Reis JD, Ferreira BP, Pereira GA, Borges MF. Assessment of basal and gonadotropin-releasing hormone-stimulated gonadotropins by immunochemiluminometric and immunofluorometric assays in normal children. J Clin Endocrinol Metab. 2007 Apr;92(4):1424-9. doi: 10.1210/jc.2006-1569. Epub 2007 Feb 6. |
| 10522992 | Background | Brito VN, Batista MC, Borges MF, Latronico AC, Kohek MB, Thirone AC, Jorge BH, Arnhold IJ, Mendonca BB. Diagnostic value of fluorometric assays in the evaluation of precocious puberty. J Clin Endocrinol Metab. 1999 Oct;84(10):3539-44. doi: 10.1210/jcem.84.10.6024. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |