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

Turner's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004274
• Other study ID #: 199/11680
• Secondary ID: TJU-11680
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: February 1990

Study information

• Verified date: October 2003
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• Estrogen

Locations

Country	Name	City	State
United States	Jefferson Medical College of Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)	Jefferson Medical College of Thomas Jefferson University

Country where clinical trial is conducted

United States,