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

NCT ID: NCT00004274

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Turner's Syndrome

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Estrogen

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jefferson Medical College of Thomas Jefferson University

OTHER

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role lead

Principal Investigators

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Judith Levine Ross

Role: STUDY_CHAIR

Jefferson Medical College of Thomas Jefferson University

Locations

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Jefferson Medical College of Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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TJU-11680

Identifier Type: -

Identifier Source: secondary_id

199/11680

Identifier Type: -

Identifier Source: org_study_id