The Effects of Estrogen on Cognition in Girls With Turner Syndrome

Status Completed

Clinical Trial Summary

The development of the brain in females is a result of a combination of factors. During puberty estrogen plays a role in influencing brain development. Cultural and environmental factors also play a role in the development of the brain.

Female patients with Turner syndrome lack the ability to produce estrogen due to undeveloped ovaries. Therefore, Turner syndrome is the perfect condition to study how estrogen (or the lack of estrogen) influences a person's behavior and thinking.

This study will compare cognitive differences (visual motor skills, visual-spatial, psychosocial behavior, and visual memory) of patients with Turner syndrome to normal patient controls. Researchers will use the Weschler Intelligence Scale for Children-Revised (WISC-R) along with other tests and scales to measure different aspects of the patient's cognitive ability. In addition the study will review patients with Turner syndrome who previously received estrogen replacement as infants and children in a related research study.

Researchers hope to demonstrate that estrogen replacement will improve cognition and behavior in girls with Turner syndrome.

Clinical Trial Description

Estrogen influences brain development in females at puberty. Environmental and cultural factors interact with the biological effects of estrogen on the brain and consequently on cognition and behavior. Turner syndrome females lack endogenous estrogen as a result of dysgenetic ovaries. Turner syndrome therefore represents a unique, estrogen-deficient model in which to study the biological effects of estrogen on cognition and behavior. The specific aims of this project are to: 1) document further, the cognitive differences between girls with Turner syndrome at ages 5 to adult (less than or equal to age 50) versus age-matched, female controls. 2) to examine the differential effects of continuous estrogen replacement in infancy and in early childhood on cognitive and social function in a unique, previously approved, randomized, double-blind, placebo-controlled, treatment trial (87-CH-0152). Specifically, we hypothesize that estrogen replacement in early childhood will reduce the cognitive deficits of girls with Turner syndrome. In addition, we hypothesize that the degree of socialization ability in these girls will correlate with social-behavioral and social recognition ability. Finally, we hypothesize that earlier (infancy to 8 years) and longer estrogen replacement will result in less impairment of visual-motor ability, visual-spatial ability, socialization ability, and affective competence compared to later (9 to 12 years) estrogen replacement in girls with Turner syndrome.

Children with Turner syndrome and controls will be tested in the Outpatient Departments at the two approved sites of protocol 87-CH-0152; the NIH and Thomas Jefferson University. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00001253
Study type	Interventional
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	Phase 2
Start date	May 1990
Completion date	March 2004

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00006334` - Turner Syndrome: Genotype and Phenotype	N/A
Not yet recruiting	`NCT02871986` - Pubertal Induction in Individuals With Hypogonadism	N/A
Completed	`NCT01306357` - Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Completed	`NCT00001221` - Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome	Phase 2
Completed	`NCT00250250` - An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG	Phase 3
Completed	`NCT00004275` - Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome	Phase 2
Completed	`NCT00013546` - Hormone Replacement Therapy to Treat Turner Syndrome	Phase 2
Terminated	`NCT02018172` - Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device	N/A
Completed	`NCT01066052` - Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years	Phase 4
Completed	`NCT01813630` - A Clinical Study to Assess the Efficacy and Safety of DA-3002	Phase 3
Completed	`NCT00004274` - Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome	N/A
Completed	`NCT00001343` - The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome	Phase 2
Terminated	`NCT00870220` - Initiating Transdermal Estradiol Therapy in Turner's Syndrome	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.