Precocious Puberty Clinical Trial
Official title:
LH Response to GnRH Test in Prepubescent Girls Under 6 Years
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 7 Months to 6 Years |
Eligibility |
Inclusion Criteria: - Endocrinologically healthy girls in the age from 7 months to 6 years - Obtained oral and written informed consent from participants parents Exclusion Criteria: - Anamnestic, clinical or laboratory findings that indicate that the subject is suffering from other diseases (eg poorly controlled asthma) or is in a condition which might affect the subject's ability to complete the study or which is likely to affect the parameters under investigation. - Current medical treatment apart from prophylactic antibiotics or weak analgesics. - GFR <50 ml/min/1,73m2 or if absence of previous GFR study: serum creatinine above normal upper age-specific normal range. - Clinical signs of precocious puberty |
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Denmark | Børneafdelingen A, AUH, Skejby | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
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. — View Citation
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. — View Citation
Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008 May 29;358(22):2366-77. doi: 10.1056/NEJMcp0800459. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2007 Feb 6. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Weight | Up till age 6.0 years | No | |
Other | Height | Up till age 6.0 years | No | |
Other | Tanner-stage (breast and pubic hair) | Up till age 6.0 years | No | |
Other | Bone age | Up till age 6.0 years | No | |
Other | Hormones (estrogen, inhibin B, SHBG, kisspeptin) | Up till age 6.0 years | No | |
Primary | LH response | 30 minutes | No | |
Secondary | FSH response | 30 minutes | No |
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