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

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

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.

Study Overview

• Status: Completed
• Conditions: Turner's Syndrome
• Intervention / Treatment: Drug: Estrogen

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 Type: Interventional
• Enrollment: 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Collaborators: Jefferson Medical College of Thomas Jefferson University
• Investigators: Study Chair: Judith Levine Ross, Jefferson Medical College of Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: February 1, 1990

Study Registration Dates

• First Submitted: October 18, 1999
• First Submitted That Met QC Criteria: October 18, 1999
• First Posted (Estimate): October 19, 1999

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: October 1, 2003

More Information

Terms related to this study

• Keywords: rare disease; genetic diseases and dysmorphic syndromes; Turner's syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Endocrine System Diseases; Disease; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Heart Defects, Congenital; Cardiovascular Abnormalities; Chromosome Disorders; Sex Chromosome Disorders; Sex Chromosome Disorders of Sex Development; Syndrome; Turner Syndrome; Gonadal Dysgenesis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens
• Other Study ID Numbers: 199/11680; TJU-11680