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NCT06083415: PENELOPE
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
NA trial testing Environmental health measures in Puberty, Precocious in 62 participants. Currently enrolling.
15 May 2026
Quick facts
| Lead sponsor | Lille Catholic University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 62 |
| Start date | 15 May 2023 |
| Primary completion | 15 May 2026 |
| Estimated completion | 15 May 2027 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Environmental health measures
Conditions studied
- Puberty, Precocious — all drugs for Puberty, Precocious →
- Breast — all drugs for Breast →
- Environmental Exposure — all drugs for Environmental Exposure →
Sponsor
Lille Catholic University
Who can join
Adults 6 to 8, female only, with Puberty, Precocious or Breast. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06083415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Puberty, Precocious
Currently open trials in the same condition.
- NCT06263868 — First Observatory of Precocious Puberty. · recruiting
- NCT04884620 — The 3rd COPENHAGEN Puberty Study · recruiting
Other Lille Catholic University trials
Trials by the same sponsor.
- NCT06634225 — Use of Inertial Units in Patient With Multiple Sclerosis (IMUSEP) · completed
- NCT06116929 — Hodgkin's Disease and Chemotherapy Before 40 Years · NA · not yet recruiting
- NCT05208099 — Study of the Immunomodulation in the Hidradenitis Suppurativa and Evaluation of a New Therapeutic Strategy · not yet recruiting
- NCT06318923 — Social and Moral Cognition in Multiple Sclerosis · NA · unknown
- NCT05607797 — Genetic of Chronic Kidney Disease and Gout in New Caledonia · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06083415 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lille Catholic University
- Last refreshed: 17 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06083415.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing