PubertyNCT07773662
Age of Puberty Onset Among Girls in Asyut, Egypt
An observational study of Puberty, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years, women only
- Conditions the study is for
- Puberty
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- 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 13 years
- Women only
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
- Conditions
- Puberty
- Keywords
- Puberty, Pubertal Onset, Thelarche, Menarche, Adolescent Health, Asyut, Egypt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PubertyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Gamal Hassan Abed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773662
- Sponsor's protocol ID
- Puberty Onset in Asyut Girls
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age at Onset of Puberty Among Girls in Asyut Governorate, Egypt
- ClinicalTrials.gov ID
- NCT07773662
- Acronym / sponsor ID
- Puberty Onset in Asyut Girls
- Conditions
- Puberty
- Keywords
- Puberty, Pubertal Onset, Thelarche, Menarche, Adolescent Health, Asyut, Egypt
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Aug 2026 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- Female only
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Age at Onset of Puberty
Time frame: Baseline
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.
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 19 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Puberty, run by Assiut University.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Age at Onset of Puberty (time frame: Baseline). 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 19 Aug 2026.