- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Age at Onset of Puberty
Délai: 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.
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Puberty Onset in Asyut Girls
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .