- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07773662
Age of Puberty Onset Among Girls in Asyut, Egypt
Age at Onset of Puberty Among Girls in Asyut Governorate, Egypt
Puberty is a critical transition from childhood to adulthood. Over the past two decades, studies worldwide have shown a trend toward earlier pubertal onset, which is thought to be influenced by factors such as lifestyle changes, improved nutrition, and environmental exposures. However, there is currently a lack of local data regarding the timing of puberty in Upper Egypt.
The main purpose of this observational study is to determine the average age at which puberty begins among girls living in the Asyut governorate, Egypt. The study specifically focuses on thelarche (breast development), which is the earliest clinical sign of pubertal onset. Additionally, the study aims to identify possible genetic, demographic, physical, and environmental factors that might influence the timing of this developmental milestone.
The study will include approximately 600 girls aged 6 to 13 years from both urban and rural areas of Asyut. Researchers will collect data during a single visit using a structured questionnaire administered through personal interviews with the participants and their parents or caregivers. The questionnaire will gather information on early life history, family history, dietary habits, physical activity, sleep patterns, screen time, stress, environmental exposures, and pubertal history. Researchers will also take basic physical measurements, including height, weight, and waist circumference to calculate Body Mass Index (BMI).
Participants will not be exposed to any invasive procedures or additional clinical risks beyond their routine care. The findings will help establish local reference values for pubertal development and support evidence-based adolescent health strategies in Egypt.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Girls aged 6-13 years showing progressive breast development.
- Reside in Asyut governorate.
- Parents/caregivers agreed to provide informed consent (and child assent when appropriate).
Exclusion Criteria:
- Premature thelarche.
- Any pathological or iatrogenic factors that will be known by history.
- Puberty due to central nervous system (CNS) lesions such as hypothalamic or pituitary tumor, hydrocephalus, etc.
- Peripheral causes of puberty such as ovarian cyst or tumor, adrenal disorders, etc.
- Endocrine disorders affecting puberty such as thyroid disorders or congenital adrenal hyperplasia.
- Chronic systemic disease affecting puberty.
- Current use of hormonal therapy.
- Incomplete clinical data or refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Girls Aged 6-13 in Asyut Governorate
This cohort consists of girls aged 6 to 13 years residing in Asyut governorate, Egypt, who are exhibiting progressive breast development (thelarche).
Participants are evaluated to determine the age of pubertal onset and to identify potential genetic, demographic, anthropometric, and environmental factors influencing this onset.
The cohort excludes girls with premature thelarche, pathological or iatrogenic causes of early puberty (such as central nervous system lesions, ovarian cysts, or thyroid disorders), chronic systemic diseases, or those currently using hormonal therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Age at Onset of Puberty
Time Frame: Baseline
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The onset of puberty will be clinically determined by the presence of thelarche (progressive glandular breast development).
The specific age of onset will be identified through a structured questionnaire administered via personal interview and clinical assessment.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Puberty Onset in Asyut Girls
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