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Clinical Trial Summary

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.


Clinical Trial Description

Please refer to the brief summary which covers the study aim, methods and outcome measures. ;


Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01944488
Study type Interventional
Source University of Aarhus
Contact Niels H. Birkebæk, MD PhD
Phone +45 50860090
Email nielbirk@rm.dk
Status Not yet recruiting
Phase N/A
Start date September 2013
Completion date September 2014

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