LH Response to GnRH Test in Prepubescent Girls Under 6 Years
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|ClinicalTrials.gov Identifier: NCT01944488|
Recruitment Status : Unknown
Verified September 2013 by University of Aarhus.
Recruitment status was: Not yet recruiting
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Precocious Puberty||Drug: GnRH agonist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LH Response to GnRH Test in Prepubescent Girls Under 6 Years|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: GnRH intervention
All participating subjects are assigned to receive an intravenous GnRH agonist injection.
Drug: GnRH agonist
100 µg/m2 body surface max 100 µg i.v.
Other Name: LHRH agonist
- LH response [ Time Frame: 30 minutes ]
- FSH response [ Time Frame: 30 minutes ]
- Weight [ Time Frame: Up till age 6.0 years ]
- Height [ Time Frame: Up till age 6.0 years ]
- Tanner-stage (breast and pubic hair) [ Time Frame: Up till age 6.0 years ]
- Bone age [ Time Frame: Up till age 6.0 years ]
- Hormones (estrogen, inhibin B, SHBG, kisspeptin) [ Time Frame: Up till age 6.0 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944488
|Contact: Niels H. Birkebæk, MD PhD||+45 email@example.com|
|Contact: Mia E. Sømod, Stud. med||+45 firstname.lastname@example.org|
|Børneafdelingen A, AUH, Skejby||Not yet recruiting|
|Aarhus N, Denmark, 8200|
|Contact: Niels H. Birkebæk, Dr.med, PhD +45 50860090 email@example.com|
|Contact: Mia E. Sømod, Stud.med +45 60199810 firstname.lastname@example.org|
|Principal Investigator: Niels H. Birkebæk, MD PhD|
|Principal Investigator: Esben T. Vestergaard, MD PhD|
|Principal Investigator: Kurt Kristensen, MD PhD|
|Sub-Investigator: Søren Rittig, MD DMSc|
|Sub-Investigator: Kostas Kamperis, MD PhD|
|Principal Investigator: Mia E. Sømod, Stud.med|
|Principal Investigator:||Niels H. Birkebæk, MD PhD||Børneafdeling A, AUH, Skejby|
|Principal Investigator:||Esben T. Vestergaard, MD PhD||Børneafdeling A, AUH, Skejby|
|Principal Investigator:||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|