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

This study has been completed.
Sponsor:
Collaborator:
Jefferson Medical College of Thomas Jefferson University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004274
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: October 2003
  Purpose

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 Intervention
Turner's Syndrome
Drug: Estrogen

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 260
Study Start Date: February 1990
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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004274

Locations
United States, Pennsylvania
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107-5083
Sponsors and Collaborators
Jefferson Medical College of Thomas Jefferson University
Investigators
Study Chair: Judith Levine Ross Jefferson Medical College of Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004274     History of Changes
Other Study ID Numbers: 199/11680, TJU-11680
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Turner's syndrome
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Syndrome
Turner Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014