Puberty, PrecociousNCT02790112

Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty

A study testing GnRHas in people with Puberty, Precocious and Adiposity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study evaluates the influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Puberty, Precocious, Adiposity
What is being tested?: GnRHas
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 418 participants
Where: 1 siteBelgium
Study dates: Apr 2016to Oct 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

History of idiopathic CPP (ICPP) treated with GnRHas.
A diagnosis of CPP made according to the following criteria: 1) secondary pubertal signs (Tanner stage 2) before 8 years in girls and 9 years in boys; 2) accelerated growth velocity (GV); 3) BA advanced for CA ≥ 1 year; 4) GnRH-stimulated peak LH >5 IU/L.
A diagnosis of idiopathic CPP according the following criteria: 1) no hypothalamic-pituitary organic lesions at magnetic resonance imaging; 2) no known medical condition that might affect the onset of puberty.
To determine whether the supposed long-term effects of treatment are instead consequences of the disease itself, untreated ICPP girls aged of ≥ 18 years, will also be included. For comparative purposes, age-matched normal (menarche > 10 y) volunteers will be recruited as a control group.

Who cannot join

In the treated ICCP group if 1) treatment with GnRHas for < 2 years; 2) non-compliance; 3) no gonadotropin suppression observed.
For all patients: 4) small for gestational age; 5) chronic disease and/or treatment; 6) being < 4 years from menarche.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200

Other trials in Belgium

About this study

Official title: Influence of Early Adiposity Rebound, Genetic Polymorphisms and GnRHa Treatment on Long-term Outcome of Girls With Idiopathic Central Precocious Puberty.

This study evaluates the influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.

Read the detailed description

Gonadotropin-releasing hormone (GnRH) analogs are the mainstay of treatment for central precocious puberty (CPP) since 1985. The relatively short time period elapsed since the introduction of this therapy has not allowed until now to carry out exhaustive studies on the long-term evolution of treated patients. This project will analyze the long-term outcomes of patients with CPP treated or not with GnRHas on adult height, body mass index, body composition, metabolic disorders, bone mineralization, gonadal function, and fertility in comparison to a control group. Overweight before puberty is associated to earlier menarche, and conversely, earlier menarche predispose to adult obesity and metabolic disorders. Nevertheless, it is unclear if adult adiposity is a direct consequence of early puberty or if early puberty is a marker of a predisposition to excess adiposity from prepuberty through adult life. Recent data in rodent models support the hypothesis that early nutritional status determines a risk for both childhood and adult obesity and influences pubertal timing. In girls, early weight gain in childhood has been associated with early menarche. Pattern of growth rather than absolute level of fatness seem to be of most importance. So the first aim of this study is to compare the outcomes of CCP patients with or without an early adiposity rebound and to demonstrate that adiposity rebound more than CPP per se or the GnRHas therapy affect the outcomes. Moreover, recent genome-wide association studies have identified obesity-related gene variants associated with earlier age at menarche. The investigators hypothesized that there might be a genetic basis underlying the early programming of both childhood and adulthood adiposity and puberty timing. The investigators thus aim to determine if those obesity-related gene variants associated with an early but not precocious menarche could also be found in CPP, especially in girls with an early adiposity rebound and if their presence may affect adult health.

Conditions: Puberty, Precocious, Adiposity
Being tested: GnRHas
Keywords: Body Mass Index, Body Composition, Glucose Metabolism Disorders, Bone Development, Gonadal Disorders, Fertility, Overweight, Obesity, Menarche
Medical subject headings: Puberty, Precocious, Obesity, Glucose Metabolism Disorders, Gonadal Disorders, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GnRHasOther
Influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group.
puberty.

Study groups in NCT02790112
Study group	Role	What they receive
GnRHas - Not GnRHas patients	Other	Compared long term outcome of treated and untreated patients with idiopathic central precocious puberty : hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA) Receives: Other: GnRHas
GnRHas - controls patients	Other	Compared long term outcome of treated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA) Receives: Other: GnRHas
Not GnRHas - Controls patients	Other	Compared long term outcome of untreated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA) Receives: Other: GnRHas

What is being measured

The primary outcome is the main question the study is designed to answer.

Single nucleotide polymorphisms (SNP) analyses
DNA analyses
Measured: 1 day

Secondary outcomes (32)

Adult height in meters
Measured at consultation
Measured: 1 day
Body mass index in kg/m2
Calculated at consultation
Measured: 1 day
Body composition in %
Dual energy x-ray absorptiometry (DXA): fat (visceral) and lean mass.
Measured: 1 day
Glucose in mg/dl
Fasting blood sampling
Measured: 1 day
Total Cholesterol in mg/dl
Fasting blood sampling
Measured: 1 day
LDL-Cholesterol in mg/dl
Metabolic assessment (fasting blood sampling)
Measured: 1 day
HDL-Cholesterol in mg/dl
Fasting blood sampling
Measured: 1 day
Insulin in microU/ml
Fasting blood sampling
Measured: 1 day
Total bone mineralization in Tscore
Dual energy x-ray absorptiometry (DXA):
Measured: 1 day
Lumbar bone mineralization in Tscore
Dual energy x-ray absorptiometry (DXA):
Measured: 1 day
Femoral neck bone mineralization in Tscore
Dual energy x-ray absorptiometry (DXA):
Measured: 1 day
Ovaries volume in ml
Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
Measured: 1 day
Ovaries follicles diameter in mm
Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
Measured: 1 day
Chronic anovulation in number
Number of mentruals cycles in a year
Measured: 1 day
SHBG by nmol/l
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Total serum testosterone by ng/dl
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Ovaries follicles counting
Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
Measured: 1 day
Abdominal perimeter in cm
Measured at consultation
Measured: 1 day
Hip perimeter in cm
Measured at consultation
Measured: 1 day
Blood pressure in mmHg
Measured at consultation
Measured: 1 day
Testicular volume in ml
Measured at consultation
Measured: 1 day
LH in IU/L
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
FSH in IU/L
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Oestradiol in ng/dl
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
DHEAS in micromol/l
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
17 hydroxyprogesterone in ng/ml
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Anti-Müllerian Hormone in ng/ml
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Inhibine in pg/ml
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Prolactine in microgr/L
Metabolic assessment (blood sampling before 10 am at the 2nd-5th day of the menstrual cycle or after 2 months of amenorrhea)
Measured: 1 day
Uterine diameter in mm
Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
Measured: 1 day
Uterine volume in ml
Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
Measured: 1 day
Endometrius thickness in mm
Pelvic ultrasound (at 2nd-5th day of the menstrual cycle)
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Oct 2018

First posted3 Jun 2016 (estimated)
Study startApr 2016
Primary completionApr 2016
Study completionOct 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Puberty, PrecociousStudies of the same condition, open and under way.
More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
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: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 418 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02790112
Sponsor's protocol ID: 2015/14OCT/549
Other IDs: RESEARCH GRANT
Status last verified: May 2016
First submitted: 25 Apr 2016
Last updated: 3 Jun 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: De-identified individual participant data for some outcome measures will be made available within 6 months of study recruitment for the Belgian Study Group for Pediatric Endocrinology.

Publications

Lee JM, Appugliese D, Kaciroti N, Corwyn RF, Bradley RH, Lumeng JC. Weight status in young girls and the onset of puberty. Pediatrics. 2007 Mar;119(3):e624-30. doi: 10.1542/peds.2006-2188.
PubMed 17332182
Lakshman R, Forouhi NG, Sharp SJ, Luben R, Bingham SA, Khaw KT, Wareham NJ, Ong KK. Early age at menarche associated with cardiovascular disease and mortality. J Clin Endocrinol Metab. 2009 Dec;94(12):4953-60. doi: 10.1210/jc.2009-1789. Epub 2009 Oct 30.
PubMed 19880785
Parent AS, Franssen D, Fudvoye J, Pinson A, Bourguignon JP. Current Changes in Pubertal Timing: Revised Vision in Relation with Environmental Factors Including Endocrine Disruptors. Endocr Dev. 2016;29:174-84. doi: 10.1159/000438885. Epub 2015 Dec 17.
PubMed 26680578
Sorensen K, Mouritsen A, Aksglaede L, Hagen CP, Mogensen SS, Juul A. Recent secular trends in pubertal timing: implications for evaluation and diagnosis of precocious puberty. Horm Res Paediatr. 2012;77(3):137-45. doi: 10.1159/000336325. Epub 2012 Apr 12.
PubMed 22508036
Copeland W, Shanahan L, Miller S, Costello EJ, Angold A, Maughan B. Outcomes of early pubertal timing in young women: a prospective population-based study. Am J Psychiatry. 2010 Oct;167(10):1218-25. doi: 10.1176/appi.ajp.2010.09081190. Epub 2010 May 17.
PubMed 20478880
Carel JC, Eugster EA, Rogol A, Ghizzoni L, Palmert MR; ESPE-LWPES GnRH Analogs Consensus Conference Group; Antoniazzi F, Berenbaum S, Bourguignon JP, Chrousos GP, Coste J, Deal S, de Vries L, Foster C, Heger S, Holland J, Jahnukainen K, Juul A, Kaplowitz P, Lahlou N, Lee MM, Lee P, Merke DP, Neely EK, Oostdijk W, Phillip M, Rosenfield RL, Shulman D, Styne D, Tauber M, Wit JM. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30.
PubMed 19332438
Klein KO, Barnes KM, Jones JV, Feuillan PP, Cutler GB Jr. Increased final height in precocious puberty after long-term treatment with LHRH agonists: the National Institutes of Health experience. J Clin Endocrinol Metab. 2001 Oct;86(10):4711-6. doi: 10.1210/jcem.86.10.7915.
PubMed 11600530
Brito VN, Latronico AC, Cukier P, Teles MG, Silveira LF, Arnhold IJ, Mendonca BB. Factors determining normal adult height in girls with gonadotropin-dependent precocious puberty treated with depot gonadotropin-releasing hormone analogs. J Clin Endocrinol Metab. 2008 Jul;93(7):2662-9. doi: 10.1210/jc.2007-2183. Epub 2008 May 6.
PubMed 18460564
Lazar L, Lebenthal Y, Yackobovitch-Gavan M, Shalitin S, de Vries L, Phillip M, Meyerovitch J. Treated and untreated women with idiopathic precocious puberty: BMI evolution, metabolic outcome, and general health between third and fifth decades. J Clin Endocrinol Metab. 2015 Apr;100(4):1445-51. doi: 10.1210/jc.2014-3748. Epub 2015 Feb 4.
PubMed 25650898
Magiakou MA, Manousaki D, Papadaki M, Hadjidakis D, Levidou G, Vakaki M, Papaefstathiou A, Lalioti N, Kanaka-Gantenbein C, Piaditis G, Chrousos GP, Dacou-Voutetakis C. The efficacy and safety of gonadotropin-releasing hormone analog treatment in childhood and adolescence: a single center, long-term follow-up study. J Clin Endocrinol Metab. 2010 Jan;95(1):109-17. doi: 10.1210/jc.2009-0793. Epub 2009 Nov 6.
PubMed 19897682
Franceschi R, Gaudino R, Marcolongo A, Gallo MC, Rossi L, Antoniazzi F, Tato L. Prevalence of polycystic ovary syndrome in young women who had idiopathic central precocious puberty. Fertil Steril. 2010 Mar 1;93(4):1185-91. doi: 10.1016/j.fertnstert.2008.11.016. Epub 2009 Jan 9.
PubMed 19135667
Barker DJ, Osmond C, Forsen TJ, Kajantie E, Eriksson JG. Trajectories of growth among children who have coronary events as adults. N Engl J Med. 2005 Oct 27;353(17):1802-9. doi: 10.1056/NEJMoa044160.
PubMed 16251536
Brockenbrough JS, Meyer SA, Li CX, Jirtle RL. Reversible and phorbol ester-specific defect of protein kinase C translocation in hepatocytes isolated from phenobarbital-treated rats. Cancer Res. 1991 Jan 1;51(1):130-6.
PubMed 1988078
Canoy D, Beral V, Balkwill A, Wright FL, Kroll ME, Reeves GK, Green J, Cairns BJ; Million Women Study Collaborators*. Age at menarche and risks of coronary heart and other vascular diseases in a large UK cohort. Circulation. 2015 Jan 20;131(3):237-44. doi: 10.1161/CIRCULATIONAHA.114.010070. Epub 2014 Dec 15.
PubMed 25512444
Colmenares A, Gunczler P, Lanes R. Higher prevalence of obesity and overweight without an adverse metabolic profile in girls with central precocious puberty compared to girls with early puberty, regardless of GnRH analogue treatment. Int J Pediatr Endocrinol. 2014;2014(1):5. doi: 10.1186/1687-9856-2014-5. Epub 2014 Apr 17.
PubMed 24742263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
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Central Precocious Puberty

All Puberty, Precocious trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Early Adiposity Rebound, Genetic Polymorphisms and GnRHa Treatment on Long-term Outcome of Girls With Idiopathic Central Precocious Puberty.
ClinicalTrials.gov ID: NCT02790112
Acronym / sponsor ID: 2015/14OCT/549
Conditions: Puberty, Precocious, Adiposity
Keywords: Body Mass Index, Body Composition, Glucose Metabolism Disorders, Bone Development, Gonadal Disorders, Fertility, Overweight, Obesity
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 418 participants (estimated)
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
Collaborators: Belgian Study Group for Pediatric Endocrinology
Study start: Apr 2016
Primary completion: Apr 2016 (actual)
Study completion: Oct 2018 (estimated)
First posted: 3 Jun 2016 (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.

This study evaluates the influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
GnRHas - Not GnRHas patients	Other	Other: GnRHasCompared long term outcome of treated and untreated patients with idiopathic central precocious puberty : hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)
GnRHas - controls patients	Other	Other: GnRHasCompared long term outcome of treated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)
Not GnRHas - Controls patients	Other	Other: GnRHasCompared long term outcome of untreated patients with idiopathic central precocious puberty and control patients for: hormonal assessment; DNA for candidate single nucleotide polymorphisms (SNP) analyses; pelvic ultrasound; dual energy x-ray absorptiometry (DXA)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

History of idiopathic CPP (ICPP) treated with GnRHas.
A diagnosis of CPP made according to the following criteria: 1) secondary pubertal signs (Tanner stage 2) before 8 years in girls and 9 years in boys; 2) accelerated growth velocity (GV); 3) BA advanced for CA ≥ 1 year; 4) GnRH-stimulated peak LH >5 IU/L.
A diagnosis of idiopathic CPP according the following criteria: 1) no hypothalamic-pituitary organic lesions at magnetic resonance imaging; 2) no known medical condition that might affect the onset of puberty.
To determine whether the supposed long-term effects of treatment are instead consequences of the disease itself, untreated ICPP girls aged of ≥ 18 years, will also be included. For comparative purposes, age-matched normal (menarche > 10 y) volunteers will be recruited as a control group.

Key exclusion criteria (2 listed)

In the treated ICCP group if 1) treatment with GnRHas for < 2 years; 2) non-compliance; 3) no gonadotropin suppression observed.
For all patients: 4) small for gestational age; 5) chronic disease and/or treatment; 6) being < 4 years from menarche.

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
GnRHasInfluence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group. puberty.	Other	GnRHas - Not GnRHas patients, GnRHas - controls patients, Not GnRHas - Controls patients

Primary outcome

Single nucleotide polymorphisms (SNP) analyses
Time frame: 1 day
DNA analyses

32 secondary outcomes

Adult height in meters
Time frame: 1 day
Body mass index in kg/m2
Time frame: 1 day
Body composition in %
Time frame: 1 day
Glucose in mg/dl
Time frame: 1 day
Total Cholesterol in mg/dl
Time frame: 1 day
LDL-Cholesterol in mg/dl
Time frame: 1 day
HDL-Cholesterol in mg/dl
Time frame: 1 day
Insulin in microU/ml
Time frame: 1 day
Total bone mineralization in Tscore
Time frame: 1 day
Lumbar bone mineralization in Tscore
Time frame: 1 day
Femoral neck bone mineralization in Tscore
Time frame: 1 day
Ovaries volume in ml
Time frame: 1 day
Ovaries follicles diameter in mm
Time frame: 1 day
Chronic anovulation in number
Time frame: 1 day
SHBG by nmol/l
Time frame: 1 day
Total serum testosterone by ng/dl
Time frame: 1 day
Ovaries follicles counting
Time frame: 1 day
Abdominal perimeter in cm
Time frame: 1 day
Hip perimeter in cm
Time frame: 1 day
Blood pressure in mmHg
Time frame: 1 day
Testicular volume in ml
Time frame: 1 day
LH in IU/L
Time frame: 1 day
FSH in IU/L
Time frame: 1 day
Oestradiol in ng/dl
Time frame: 1 day
DHEAS in micromol/l
Time frame: 1 day
17 hydroxyprogesterone in ng/ml
Time frame: 1 day
Anti-Müllerian Hormone in ng/ml
Time frame: 1 day
Inhibine in pg/ml
Time frame: 1 day
Prolactine in microgr/L
Time frame: 1 day
Uterine diameter in mm
Time frame: 1 day
Uterine volume in ml
Time frame: 1 day
Endometrius thickness in mm
Time frame: 1 day

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
Background: PubMed 17332182Lee JM, Appugliese D, Kaciroti N, Corwyn RF, Bradley RH, Lumeng JC. Weight status in young girls and the onset of puberty. Pediatrics. 2007 Mar;119(3):e624-30. doi: 10.1542/peds.2006-2188.
Background: PubMed 19880785Lakshman R, Forouhi NG, Sharp SJ, Luben R, Bingham SA, Khaw KT, Wareham NJ, Ong KK. Early age at menarche associated with cardiovascular disease and mortality. J Clin Endocrinol Metab. 2009 Dec;94(12):4953-60. doi: 10.1210/jc.2009-1789. Epub 2009 Oct 30.
Background: PubMed 26680578Parent AS, Franssen D, Fudvoye J, Pinson A, Bourguignon JP. Current Changes in Pubertal Timing: Revised Vision in Relation with Environmental Factors Including Endocrine Disruptors. Endocr Dev. 2016;29:174-84. doi: 10.1159/000438885. Epub 2015 Dec 17.
Background: PubMed 22508036Sorensen K, Mouritsen A, Aksglaede L, Hagen CP, Mogensen SS, Juul A. Recent secular trends in pubertal timing: implications for evaluation and diagnosis of precocious puberty. Horm Res Paediatr. 2012;77(3):137-45. doi: 10.1159/000336325. Epub 2012 Apr 12.
Background: PubMed 20478880Copeland W, Shanahan L, Miller S, Costello EJ, Angold A, Maughan B. Outcomes of early pubertal timing in young women: a prospective population-based study. Am J Psychiatry. 2010 Oct;167(10):1218-25. doi: 10.1176/appi.ajp.2010.09081190. Epub 2010 May 17.
Background: PubMed 19332438Carel JC, Eugster EA, Rogol A, Ghizzoni L, Palmert MR; ESPE-LWPES GnRH Analogs Consensus Conference Group; Antoniazzi F, Berenbaum S, Bourguignon JP, Chrousos GP, Coste J, Deal S, de Vries L, Foster C, Heger S, Holland J, Jahnukainen K, Juul A, Kaplowitz P, Lahlou N, Lee MM, Lee P, Merke DP, Neely EK, Oostdijk W, Phillip M, Rosenfield RL, Shulman D, Styne D, Tauber M, Wit JM. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30.
Background: PubMed 11600530Klein KO, Barnes KM, Jones JV, Feuillan PP, Cutler GB Jr. Increased final height in precocious puberty after long-term treatment with LHRH agonists: the National Institutes of Health experience. J Clin Endocrinol Metab. 2001 Oct;86(10):4711-6. doi: 10.1210/jcem.86.10.7915.
Background: PubMed 18460564Brito VN, Latronico AC, Cukier P, Teles MG, Silveira LF, Arnhold IJ, Mendonca BB. Factors determining normal adult height in girls with gonadotropin-dependent precocious puberty treated with depot gonadotropin-releasing hormone analogs. J Clin Endocrinol Metab. 2008 Jul;93(7):2662-9. doi: 10.1210/jc.2007-2183. Epub 2008 May 6.
Background: PubMed 25650898Lazar L, Lebenthal Y, Yackobovitch-Gavan M, Shalitin S, de Vries L, Phillip M, Meyerovitch J. Treated and untreated women with idiopathic precocious puberty: BMI evolution, metabolic outcome, and general health between third and fifth decades. J Clin Endocrinol Metab. 2015 Apr;100(4):1445-51. doi: 10.1210/jc.2014-3748. Epub 2015 Feb 4.
Background: PubMed 19897682Magiakou MA, Manousaki D, Papadaki M, Hadjidakis D, Levidou G, Vakaki M, Papaefstathiou A, Lalioti N, Kanaka-Gantenbein C, Piaditis G, Chrousos GP, Dacou-Voutetakis C. The efficacy and safety of gonadotropin-releasing hormone analog treatment in childhood and adolescence: a single center, long-term follow-up study. J Clin Endocrinol Metab. 2010 Jan;95(1):109-17. doi: 10.1210/jc.2009-0793. Epub 2009 Nov 6.
Background: PubMed 19135667Franceschi R, Gaudino R, Marcolongo A, Gallo MC, Rossi L, Antoniazzi F, Tato L. Prevalence of polycystic ovary syndrome in young women who had idiopathic central precocious puberty. Fertil Steril. 2010 Mar 1;93(4):1185-91. doi: 10.1016/j.fertnstert.2008.11.016. Epub 2009 Jan 9.
Background: PubMed 16251536Barker DJ, Osmond C, Forsen TJ, Kajantie E, Eriksson JG. Trajectories of growth among children who have coronary events as adults. N Engl J Med. 2005 Oct 27;353(17):1802-9. doi: 10.1056/NEJMoa044160.
Individual participant dataSharing planned: Yes. De-identified individual participant data for some outcome measures will be made available within 6 months of study recruitment for the Belgian Study Group for Pediatric Endocrinology.

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Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Central Precocious Puberty

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.

Constanza Navarro Moreno, D principal investigator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GnRHas in people with Puberty, Precocious and Adiposity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. 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 Belgium. 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. 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?

Results are not available in the source record.

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?

Single nucleotide polymorphisms (SNP) analyses (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02790112, which also lists 23 linked publications.

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 3 Jun 2016.