Puberty, PrecociousNCT02431416
Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Premature Puberty
A study testing Gonadotropin releasing hormone (GnRH) and Sodium Chloride in people with Puberty, Precocious, run by Region Örebro County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older, women only
- Conditions the study is for
- Puberty, Precocious
- What is being tested?
- Gonadotropin releasing hormone (GnRH) and Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- May 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female gender.
- Clinical suspicion of central precocious puberty.
- A GnRH stimulation test is to be performed to make appropriate diagnosis.
Who cannot join
- Age < 1 year.
- Weight < 10 kg.
- Untreated hypo- or hyperthyroidism.
- Diabetes of any kind.
- BMI > 3 z-score.
- Growth hormone treatment.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Paediatrics, Örebro University Hospital
Örebro, 701 85
About this study
Official title: Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty
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.
Read the detailed description
Patients with clinically suspected central premature puberty undergo a GnRH stimulation test to have an appropriate diagnosis. 20 such girls will be recruited to this study and a modified GnRH stimulation test will be done. The modification includes prolonged blood sampling time (0, 30, 60, 90, 120, and 150 min after the GnRH injection instead of the usual 0, 30, 60, and 90 min). The girls will also be investigated twice. In randomised order they will be given either GnRH or placebo (isotone saline), on different days. One week to one month will separate the different investigation days.
The proteinase inhibitor 4-(2-aminoethyl) benzene-sulfonyl fluoride hydrochlorid (AEBSF) will be added to some of the blood tubes, and hydrochloric acid will be added to some of the plasma. All plasma samples will be frozen and all analyses will be done at the same time. Acylated ghrelin will be analyzed by Millipore's specific ELISA kit and deacylated ghrelin will be analyzed by Cayman's specific ELISA kit.
Anthropometric data as well as pubertal state will be collected. P-glucose, S-insulin, S-follicle stimulating hormone (FSH), S-luteinizing hormone (LH), and S-estradiol will also be analyzed.
- Conditions
- Puberty, Precocious
- Being tested
- Gonadotropin releasing hormone (GnRH), Sodium Chloride
- Keywords
- females, ghrelin, GnRH, randomized, controlled study, children
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin releasing hormone (GnRH)Drug
Also called Relefact LHRH
Gonadotropin releasing hormone GnRH (Relefact LHRH) iv injection, single dose, 100 micrograms/square meter body surface, maximum dose: 100 microgram.
Sodium ChlorideDrug
Also called Saline, placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Concentrations of deacylated ghrelin will be compared between different handling procedures.
Measured: 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
Deacylated ghrelin concentrations will be compared at 150 min after iv injections between different handling procedures.
Measured: 150 min after iv injections
Acylated ghrelin concentrations in samples treated with and without hydrochloric acid
Acylated ghrelin concentrations will be compared between different handling procedures.
Measured: 0-150 min after iv injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puberty, PrecociousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Responsible party
- Sponsor
- Investigators
- Maria Lodefalk, MD, PhD, Principal investigator, Department of Paediatrics, Faculty of Medicine and Health, Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431416
- Sponsor's protocol ID
- OLL-430981
- Status last verified
- Mar 2019
- First submitted
- 10 Apr 2015
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty
- ClinicalTrials.gov ID
- NCT02431416
- Acronym / sponsor ID
- OLL-430981
- Conditions
- Puberty, Precocious
- Keywords
- females, ghrelin, GnRH, randomized, controlled study, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with clinically suspected central premature puberty undergo a GnRH stimulation test to have an appropriate diagnosis. 20 such girls will be recruited to this study and a modified GnRH stimulation test will be done. The modification includes prolonged blood sampling time (0, 30, 60, 90, 120, and 150 min after the GnRH injection instead of the usual 0, 30, 60, and 90 min). The girls will also be investigated twice. In randomised order they will be given either GnRH or placebo (isotone saline), on different days. One week to one month will separate the different investigation days.
The proteinase inhibitor 4-(2-aminoethyl) benzene-sulfonyl fluoride hydrochlorid (AEBSF) will be added to some of the blood tubes, and hydrochloric acid will be added to some of the plasma. All plasma samples will be frozen and all analyses will be done at the same time. Acylated ghrelin will be analyzed by Millipore's specific ELISA kit and deacylated ghrelin will be analyzed by Cayman's specific ELISA kit.
Anthropometric data as well as pubertal state will be collected. P-glucose, S-insulin, S-follicle stimulating hormone (FSH), S-luteinizing hormone (LH), and S-estradiol will also be analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gonadotropin releasing hormone (GnRH) | Active comparator | Drug: Gonadotropin releasing hormone (GnRH)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. |
| Sodium chloride | Placebo comparator | Drug: Sodium ChlorideA 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female gender.
- Clinical suspicion of central precocious puberty.
- A GnRH stimulation test is to be performed to make appropriate diagnosis.
Key exclusion criteria (9 listed)
- Age < 1 year.
- Weight < 10 kg.
- Untreated hypo- or hyperthyroidism.
- Diabetes of any kind.
- BMI > 3 z-score.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonadotropin releasing hormone (GnRH)Also: Relefact LHRHGonadotropin releasing hormone GnRH (Relefact LHRH) iv injection, single dose, 100 micrograms/square meter body surface, maximum dose: 100 microgram. | Drug | Gonadotropin releasing hormone (GnRH) |
| Sodium ChlorideAlso: Saline, placeboSodium 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. | Drug | Sodium chloride |
Primary outcome
Ghrelin concentration after GnRH injection and after saline injection
Time frame: 30-150 min after iv injections
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.
3 secondary outcomes
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
Time frame: 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
Time frame: 150 min after iv injections
Acylated ghrelin concentrations in samples treated with and without hydrochloric acid
Time frame: 0-150 min after iv injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Lodefalk, MD, PhD principal investigator
Department of Paediatrics, Faculty of Medicine and Health, Örebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin releasing hormone (GnRH) and Sodium Chloride in people with Puberty, Precocious, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghrelin concentration after GnRH injection and after saline injection (time frame: 30-150 min after iv injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.