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LH Response to GnRH Test in Prepubescent Girls Under 6 Years

NCT01944488 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-09-17

No results posted yet for this study

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.

Conditions

  • Precocious Puberty

Interventions

DRUG

GnRH agonist

100 µg/m2 body surface max 100 µg i.v.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels H. Birkebæk, MD PhD · Børneafdeling A, AUH, Skejby

  • Esben T. Vestergaard, MD PhD · Børneafdeling A, AUH, Skejby

  • Kurt Kristensen, MD PhD · Børneafdeling A, AUH, Skejby

  • Søren Rittig, MD DMSc · Børneafdeling A, AUH, Skejby

  • Kostas Kamperis, MD PhD · Børneafdeling A, AUH, Skejby

  • Mia E. Sømod, Stud.med · Børneafdelig A, AUH, Skejby

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Months
Max Age
6 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944488 on ClinicalTrials.gov