NCT07773662

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Oct 2027

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 14, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

PubertyPubertal OnsetThelarcheMenarcheAdolescent HealthAsyutEgypt

Outcome Measures

Primary Outcomes (1)

  • Mean Age at Onset of Puberty

    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.

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age6 Years - 13 Years
Sexfemale
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population consists of girls aged 6 to 13 years residing in urban and rural areas of the Asyut governorate in Egypt who are exhibiting progressive breast development. Participants will be recruited from eligible girls attending selected primary health care centers, family health centers, and family health units across the East Nile and West Nile sectors of the governorate. The final population is designed to include approximately 400 girls from rural areas and 200 girls from urban areas.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Family Medicine

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08