Clincosm LogoSign in Get a demo

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Sponsor
University of Aarhus (Other)
Overall Status
Unknown status
CT.gov ID
NCT01944488
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: GnRH agonist
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
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
Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2014
Anticipated Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • LHRH agonist

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LH response [30 minutes]

    Secondary Outcome Measures

    1. FSH response [30 minutes]

    Other Outcome Measures

    1. Weight [Up till age 6.0 years]

    2. Height [Up till age 6.0 years]

    3. Tanner-stage (breast and pubic hair) [Up till age 6.0 years]

    4. Bone age [Up till age 6.0 years]

    5. Hormones (estrogen, inhibin B, SHBG, kisspeptin) [Up till age 6.0 years]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Børneafdelingen A, AUH, Skejby Aarhus N Denmark 8200

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01944488
    Other Study ID Numbers:
    • 1-10-72-631-12
    First Posted:
    Sep 17, 2013
    Last Update Posted:
    Sep 17, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by University of Aarhus
    Precocious puberty
    GnRH-test
    Additional relevant MeSH terms:
    Puberty, Precocious

    Study Results

    No Results Posted as of Sep 17, 2013