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

This study has been completed.

Sponsors and Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) Jefferson Medical College of Thomas Jefferson University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004274

Purpose

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.

Condition	Intervention
Turner's Syndrome	Drug: Estrogen

Genetics Home Reference related topics: Turner syndrome

MedlinePlus related topics: Turner Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	260
Study Start Date:	February 1990

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004274

Locations

United States, Pennsylvania
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107-5083

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Jefferson Medical College of Thomas Jefferson University

Investigators

Study Chair:

Judith Levine Ross

Jefferson Medical College of Thomas Jefferson University

More Information

Study ID Numbers:	199/11680, TJU-11680
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004274
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

Turner's syndrome
genetic diseases and dysmorphic syndromes
rare disease

Study placed in the following topic categories:

Chromosomal abnormalities
Genital dwarfism
Gonadal Disorders
Rare Diseases
Chromosome Disorders
Endocrine System Diseases
Sex Differentiation Disorders
Monosomy X
Turner Syndrome

Gonadal dysgenesis
Urogenital Abnormalities
Genetic Diseases, Inborn
Turner syndrome
Ovarian dwarfism
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Sex Chromosome Disorders

ClinicalTrials.gov processed this record on January 16, 2009