NCT02431416

Brief Summary

The purposes of the study is to investigate whether circulating levels of ghrelin decreases after an iv injection of GnRH in girls with suspected central premature puberty and to investigate the effects of different post sampling handling on the preservation of acylated ghrelin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

April 10, 2015

Last Update Submit

March 28, 2019

Conditions

Puberty, Precocious

Keywords

femalesghrelinGnRHrandomized, controlled studychildren

Outcome Measures

Primary Outcomes (1)

  • Ghrelin concentration after GnRH injection and after saline injection

    Paired comparison will be done between the acylated ghrelin concentration after GnRH injection and the acylated ghrelin concentration after saline injection. Paired comparison will also be done between deacylated ghrelin concentration after GnRH injection and deacylated ghrelin concentration after saline injection.

    30-150 min after iv injections

Secondary Outcomes (3)

  • Deacylated ghrelin concentrations in samples treated with the inhibitor AEBSF, in samples treated with both AEBSF and hydrochloric acid, and in samples not treated with either AEBSF or hydrochloric acid

    At baseline

  • Deacylated ghrelin concentrations in samples treated with the inhibitor AEBSF, in samples treated with both AEBSF and hydrochloric acid, and in samples not treated with either AEBSF or hydrochloric acid

    150 min after iv injections

  • Acylated ghrelin concentrations in samples treated with and without hydrochloric acid

    0-150 min after iv injections

Study Arms (2)

Gonadotropin releasing hormone (GnRH)

ACTIVE COMPARATOR

A single intravenous injection of gonadotropin releasing hormone GnRH (Relefact LHRH 0,1 mg/mL). Dose: 100 micrograms per square meter body surface. Maximal dose: 100 micrograms.

Drug: Gonadotropin releasing hormone (GnRH)

Sodium chloride

PLACEBO COMPARATOR

A single intravenous injection of sodium chlorid (9 mg/mL). Dose: the same volume as the volume given/to be given with GnRH, that is maximal dose = 1 mL = 9 mg sodium chlorid.

Drug: Sodium Chloride

Interventions

Gonadotropin releasing hormone (GnRH)DRUG

Gonadotropin releasing hormone GnRH (Relefact LHRH) iv injection, single dose, 100 micrograms/square meter body surface, maximum dose: 100 microgram.

Also known as: Relefact LHRH
Gonadotropin releasing hormone (GnRH)
Sodium ChlorideDRUG

Sodium chlorid 9 mg/mL will be given as a single iv injection with the same volume as the volume used for the active substance injection.

Also known as: Saline, placebo
Sodium chloride

Eligibility Criteria

Age1 Year+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female gender.
  • Clinical suspicion of central precocious puberty.
  • A GnRH stimulation test is to be performed to make appropriate diagnosis.

You may not qualify if:

  • Age \< 1 year.
  • Weight \< 10 kg.
  • Untreated hypo- or hyperthyroidism.
  • Diabetes of any kind.
  • BMI \> 3 z-score.
  • Growth hormone treatment.
  • Syndrome or suspected syndrome.
  • Tumour or congenital malformation of the hypothalamus or the pituitary gland. (Neuroradiology does not have to be performed only because of the study.)
  • On going ulcus ventriculi or the patient has gone through surgery that removed part of the ventricle or changed it markedly in any other way.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics, Örebro University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Gonadotropin-Releasing HormoneSodium Chloride

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Maria Lodefalk, MD, PhD

    Department of Paediatrics, Faculty of Medicine and Health, Örebro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

May 1, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)