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

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004274

Collaborator

Jefferson Medical College of Thomas Jefferson University (Other)

260

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Turner's Syndrome	Drug: Estrogen	N/A

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 1990

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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