Back to resultsEffect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
Primary Purpose
Turner's Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Estrogen
Sponsored by
About this trial
This is an interventional treatment trial for Turner's Syndrome focused on measuring Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
Eligibility 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
Sites / Locations
- Jefferson Medical College of Thomas Jefferson University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004274
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators
Jefferson Medical College of Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT00004274
Brief Title
Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
Official Title
Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2003
Overall Recruitment Status
Completed
Study Start Date
February 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators
Jefferson Medical College of Thomas Jefferson University
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner's Syndrome
Keywords
Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
260 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Estrogen
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Levine Ross
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Jefferson Medical College of Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5083
Country
United States
12. IPD Sharing Statement
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Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
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