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Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context

Study acronym: PENELOPE
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 17, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Enrollment target: 50 to 62
    • Eligibility criteria expanded, about 116 words
    • Study arms: 1 to 2
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06083415
Lead Sponsor Lille Catholic University
Conditions
(from sponsor)		 Puberty, Precocious, Breast, Environmental Exposure
Related terms Puberty, Precocious
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov