Trial record 17 of 29 for:    "Precocious puberty"

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01944488
First received: September 6, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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 Intervention
Precocious Puberty
Drug: GnRH agonist

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • LH response [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FSH response [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Weight [ Time Frame: Up till age 6.0 years ] [ Designated as safety issue: No ]
  • Height [ Time Frame: Up till age 6.0 years ] [ Designated as safety issue: No ]
  • Tanner-stage (breast and pubic hair) [ Time Frame: Up till age 6.0 years ] [ Designated as safety issue: No ]
  • Bone age [ Time Frame: Up till age 6.0 years ] [ Designated as safety issue: No ]
  • Hormones (estrogen, inhibin B, SHBG, kisspeptin) [ Time Frame: Up till age 6.0 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   7 Months to 6 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944488

Contacts
Contact: Niels H. Birkebæk, MD PhD +45 50860090 nielbirk@rm.dk
Contact: Mia E. Sømod, Stud. med +45 60199810 mia.elbek.somod@studmed.au.dk

Locations
Denmark
Børneafdelingen A, AUH, Skejby Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Niels H. Birkebæk, Dr.med, PhD    +45 50860090    nielbirk@rm.dk   
Contact: Mia E. Sømod, Stud.med    +45 60199810    mia.elbek.somod@studmed.au.dk   
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         
Sponsors and Collaborators
University of Aarhus
Investigators
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
  More Information

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01944488     History of Changes
Other Study ID Numbers: 1-10-72-631-12
Study First Received: September 6, 2013
Last Updated: September 12, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Precocious puberty
GnRH-test

Additional relevant MeSH terms:
Puberty, Precocious
Endocrine System Diseases
Gonadal Disorders
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014