Puberty, PrecociousPENELOPENCT06083415
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
A study testing Environmental health measures in people with Puberty, Precocious and Breast, run by Lille Catholic University at 2 sites in France.
Trial summary
Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. Read more about this study
- Who is it for?
- Ages 6 to 8 years, women only
- Conditions the study is for
- Puberty, Precocious, Breast, Environmental Exposure
- What is being tested?
- Environmental health measures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 15 May 2023to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 8 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Girls aged 6 to 8 years
- Presenting a breast development (isolated or not)
- Undergoing scheduled pediatric day hospital care (HDJ)
- Who agree to participate in the study
- Whose parents agree to their child's participation in the study
- French speaking
Show all 16Show fewer
- Whose parents speak French
- Affiliated to social security
- Girls aged 6 to 8
- Tanner stage 1: Absence of breasts and hairiness
- Coming for routine consultation in the pediatric HDJ at Saint-Vincent-de-Paul hospital, or at the BLM practice in Lambersart, or to radiology for an MRI for another medical other medical reason
- Agree to participate in the study
- Whose parents agree to their child's participation in the the study
- French-speaking
- Whose parents speak French
- Affiliated with social security
Who cannot join
- Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)
- Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia
- History of chemotherapy or radiation therapy
- Presenting with a communication disorder
- Pregnancy
- Persons under protective measures
Show all 14Show fewer
- Persons deprived of liberty for judicial or administrative reasons
- For controls:
- Signs of puberty (Tanner stages 2, 3, 4 and 5 for breast development) breast development)
- Previous chemotherapy or radiotherapy
- Presenting a communication disorder
- Pregnant women
- Persons under protective supervision
- Persons deprived of their liberty for judicial or administrative reasons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Cabinet BLM
Lambersart, Hauts-de-France, 59130
Patricia RANNAUD-BARTAIRE, PhD, bartaire.patricia@ghicl.net
Patricia RANNAUD-BARTAIRE
- Recruiting
Saint Vincent hospital
Lille, Hauts-de-France, 59000
Patricia RANNAUD-BARTAIRE, PhD, bartaire.patricia@ghicl.net
Patricia RANNAUD-BARTAIRE, PhD
About this study
Official title: Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures
Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.
Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.
Read more
The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.
The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.
- Conditions
- Puberty, Precocious, Breast, Environmental Exposure
- Being tested
- Environmental health measures
- Keywords
- Early puberty, Endocrine disruptors, Girls, Breast growth, Environmental Health Measure
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental health measuresOther
Also called Magnetic Resonance Imaging (MRI), Blood tests, Determination of endocrine disruptors in hair, Urine tests
MRI will be used to confirm the presence of breast buds, to measure the size of the ovaries and uterus, as well as the fraction of fat mass (abdominal, subcutaneous, liver and bone marrow). The bood and urine tests will allow to measure different biological and metabolic parameters. The presence of endocrine disruptors will be determined in the hair. The bone age x ray will be estimate the maturity of the child's skeletal system. Photographs of the teeth will also be taken to be studied by pediatric odontology researchers on the on molar and incisor hypomineralization, known as MIH.
| Study group | Role | What they receive |
|---|---|---|
| 6 to 8 years old girls, presenting with a breast flare-up | Experimental | Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay Receives: Other: Environmental health measures |
| 6 to 8 years old girls controls | No intervention | Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of breast development after application of environmental health measures
Measured: Baseline, 3 months
Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures
Measured: Baseline, 3 months,
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of the abdominal fat surface after application of environmental health measures
Measured: Baseline, 3 months
Change from baseline of the weight
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures
Measured: Baseline, 3 months, 6 months
Change from baseline of the height
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures
Measured: Baseline, 3 months, 6 months
Body mass index (BMI)
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures
Measured: Baseline, 3 months, 6 months
Secondary outcomes (19)
Measurement of endocrine disruptors in hair
Describe the evolution of the amount of endocrine disruptors in hair after the implementation of environmental health measures. from 70 to 100 mg of hair will cut as close as possible to the scalp at the posterior vertex, and stored at room temperature to measure endocrine disruptors such as parabens, phthalates, bisphenols and pesticides.
Measured: Change from baseline at 90 days
Tanner scale
The Tanner scale is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on external primary and secondary sex characteristics.
Breast:
Tanner I: no glandular tissue Tanner II: breast bud forms, areola begins to widen Tanner III: breast begins to become more elevated, and extends beyond the borders of the areola, Tanner IV: increased breast sizing and elevation; areola and papilla form a secondary mound projecting from the contour of the surrounding breast Tanner V: breast reaches final adult size
Pubis hair:
Tanner I: no pubic hair Tanner II: small amount of long, downy hair Tanner III: hair becomes more coarse and curly, and begins to extend laterally Tanner IV: adult-like hair quality, extending across pubis but sparing medial thighs Tanner V: hair extends to medial surface of the thighs
Measured: Change from baseline at 90 and 180 days
Bone age determination by X ray
Determination of bone age to determine the maturity of the child's skeletal system.
Measured: Change from baseline at 90
Degree of severity of teeth hypomineralisation
The dree of severity is determine according to a scale: 1: <30% of the tooth's enamel surface area visibly disrupted, 2: 31 to 49% of the tooth's enamel surface area visibly disrupted, 3: >50% of the tooth's enamel surface area visibly disrupted
Measured: Baseline, 3 months
Follicle-stimulating hormone (FSH) level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Estradiol (E2) level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Testosterone Level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
17 hydroxyprogesterone level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Dehydroepiandrosterone sulfate level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Sex Hormone-Binding Globulin level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Thyroid Stimulating Hormone level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
FT4 (Free Thyroxine hormone) level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Androstenedione level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Insulin level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Glycated hemoglobin (HbA1C) level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Insulin-like Growth Factor-1 level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Leptine level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Luteinizing hormone (LH) level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Glycemia level
Blood test for determining the evolution of this parameter from baseline
Measured: Change from baseline at 90 days and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 May 2023
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2027 (estimated)
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia RANNAUD-BARTAIRE, PhD, Principal investigator, Hôpital Saint-Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083415
- Sponsor's protocol ID
- RT-17
- Acronym
- PENELOPE
- Status last verified
- Mar 2026
- First submitted
- 4 Oct 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures
- ClinicalTrials.gov ID
- NCT06083415
- Acronym / sponsor ID
- PENELOPE / RT-17
- Conditions
- Puberty, Precocious, Breast, Environmental Exposure
- Keywords
- Early puberty, Endocrine disruptors, Girls, Breast growth, Environmental Health Measure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 16 Oct 2023 (actual)
- 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.
Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.
Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.
The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.
The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 to 8 years old girls, presenting with a breast flare-up | Experimental | Other: Environmental health measuresGirls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay |
| 6 to 8 years old girls controls | No intervention | –Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Girls aged 6 to 8 years
- Presenting a breast development (isolated or not)
- Undergoing scheduled pediatric day hospital care (HDJ)
- Who agree to participate in the study
- Whose parents agree to their child's participation in the study
Key exclusion criteria (14 listed)
- Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)
- Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia
- History of chemotherapy or radiation therapy
- Presenting with a communication disorder
- Pregnancy
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 |
|---|---|---|
| Environmental health measuresAlso: Magnetic Resonance Imaging (MRI), Blood tests, Determination of endocrine disruptors in hair, Urine testsMRI will be used to confirm the presence of breast buds, to measure the size of the ovaries and uterus, as well as the fraction of fat mass (abdominal, subcutaneous, liver and bone marrow). The bood and urine tests will allow to measure different biological and metabolic parameters. The presence of endocrine disruptors will be determined in the hair. The bone age x ray will be estimate the maturity of the child's skeletal system. Photographs of the teeth will also be taken to be studied by pediatric odontology researchers on the on molar and incisor hypomineralization, known as MIH. | Other | 6 to 8 years old girls, presenting with a breast flare-up |
Primary outcome
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
Time frame: Baseline, 3 months
This parameter will allow to describe the clinical evolution of breast development after application of environmental health measures
Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
Time frame: Baseline, 3 months,
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
Time frame: Baseline, 3 months
This parameter will allow to describe the clinical evolution of the abdominal fat surface after application of environmental health measures
Change from baseline of the weight
Time frame: Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures
Change from baseline of the height
Time frame: Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures
Body mass index (BMI)
Time frame: Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures
19 secondary outcomes
Measurement of endocrine disruptors in hair
Time frame: Change from baseline at 90 days
Tanner scale
Time frame: Change from baseline at 90 and 180 days
Bone age determination by X ray
Time frame: Change from baseline at 90
Degree of severity of teeth hypomineralisation
Time frame: Baseline, 3 months
Follicle-stimulating hormone (FSH) level
Time frame: Change from baseline at 90 days and 180 days
Estradiol (E2) level
Time frame: Change from baseline at 90 days and 180 days
Testosterone Level
Time frame: Change from baseline at 90 days and 180 days
17 hydroxyprogesterone level
Time frame: Change from baseline at 90 days and 180 days
Dehydroepiandrosterone sulfate level
Time frame: Change from baseline at 90 days and 180 days
Sex Hormone-Binding Globulin level
Time frame: Change from baseline at 90 days and 180 days
Thyroid Stimulating Hormone level
Time frame: Change from baseline at 90 days and 180 days
FT4 (Free Thyroxine hormone) level
Time frame: Change from baseline at 90 days and 180 days
Androstenedione level
Time frame: Change from baseline at 90 days and 180 days
Insulin level
Time frame: Change from baseline at 90 days and 180 days
Glycated hemoglobin (HbA1C) level
Time frame: Change from baseline at 90 days and 180 days
Insulin-like Growth Factor-1 level
Time frame: Change from baseline at 90 days and 180 days
Leptine level
Time frame: Change from baseline at 90 days and 180 days
Luteinizing hormone (LH) level
Time frame: Change from baseline at 90 days and 180 days
Glycemia level
Time frame: Change from baseline at 90 days and 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- 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.
Patricia RANNAUD-BARTAIRE, PhD principal investigator
Hôpital Saint-Vincent de Paul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental health measures in people with Puberty, Precocious and Breast, run by Lille Catholic University at 2 sites in France.
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 16 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Paule LEBITASY (03.20.22.52.69 ext. +33, lebitasy.marie-paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging (time frame: Baseline, 3 months). The study lists 6 primary outcomes in all. 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 17 Mar 2026.