Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome

RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning problems experienced by girls with Turner's syndrome.

PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental and social functioning in girls who have Turner's syndrome.

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Key information

Conditions

Turner's Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

8 year–12 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Medical College of Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-5083, United States

About this study

PROTOCOL OUTLINE: Participants are evaluated for cognitive and social function at entry and 4 years following entry. Assessments include the Wechsler Intelligence Scale for Children-Revised, a child behavior checklist, the Children's Self-Concept Scale, and visual-spatial, visual-motor, attention, memory, language, and facial recognition tasks.

Patients (and parents) undergo X-chromosome analysis; brain magnetic imaging is optional.

Controls are matched using school selection and telephone interviews.

A study duration of 12 years is estimated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

PROTOCOL ENTRY CRITERIA:

Girls aged 8 and 12 years with Turner's syndrome-compatible karyotype
Age-matched girls without Turner's syndrome entered as controls
Concurrent registration on Thomas Jefferson University growth study required of subjects with Turner's syndrome

Treatment and study plan

Estrogen

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Nih

Collaborators

Jefferson Medical College of Thomas Jefferson University

Registry information

Official study title

Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome

Important dates

Study start: 1990
First posted: Oct 19, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed