We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by University of Aarhus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01944488
First Posted: September 17, 2013
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • FSH response [ Time Frame: 30 minutes ]

Other Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   7 Months to 6 Years   (Child)
Sexes 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
Information from the National Library of Medicine

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


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
First Submitted: September 6, 2013
First Posted: September 17, 2013
Last Update Posted: September 17, 2013
Last Verified: September 2013

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

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