Philadelphia, Pennsylvania 19107

  • Turner's Syndrome

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.


Study summary:

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.


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


Study is Available At:


Original ID:

199/11680


NCT ID:

NCT00004274


Secondary ID:

TJU-11680


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

8 Years


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Office of Rare Diseases (ORD)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

260


Enrollment Type:


Overall Contact Information

Official Name:Judith Levine Ross
Study Chair
Jefferson Medical College of Thomas Jefferson University

Study Dates

Start Date:February 1990
Verification Date:October 2003
Last Changed Date:June 23, 2005
First Received Date:October 18, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Estrogen

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Neurological Disorders and Stroke (NINDS)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Jefferson Medical College of Thomas Jefferson University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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