Turner's SyndromeNCT00004274
Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
A study testing Estrogen in people with Turner's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner's Syndrome
- What is being tested?
- Estrogen
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1990to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- Women only
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-5083
About this study
Official title: 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.
Read the 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.
- Conditions
- Turner's Syndrome
- Being tested
- Estrogen
- Keywords
- Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
- Medical subject headings
- Turner Syndrome, Genetic Diseases, Inborn, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startFeb 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner's SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 260 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Jefferson Medical College of Thomas Jefferson University
- Investigators
- Judith Levine Ross, Study chair, Jefferson Medical College of Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004274
- Sponsor's protocol ID
- 199/11680
- Other IDs
- TJU-11680
- Status last verified
- Oct 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome
- ClinicalTrials.gov ID
- NCT00004274
- Acronym / sponsor ID
- 199/11680
- Conditions
- Turner's Syndrome
- Keywords
- Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Jefferson Medical College of Thomas Jefferson University
- Study start
- Feb 1990
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estrogen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Levine Ross study chair
Jefferson Medical College of Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogen in people with Turner's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.