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Estrogen and Gender Biased Autoimmunity

NCT ID: NCT00519454

Last Updated: 2010-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2013-12-31

Brief Summary

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This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

Detailed Description

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This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Female Lupus patients

Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.

Peripheral lab draws

Intervention Type OTHER

100ml blood for analysis, taken no more than 4 times in one year.

Interventions

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Peripheral lab draws

100ml blood for analysis, taken no more than 4 times in one year.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.

Exclusion Criteria

* Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

The Center for Rheumatic Disease, Allergy, & Immunology

OTHER

Sponsor Role lead

Responsible Party

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Center for Rheumatic Disease Allergy & Immunology

Principal Investigators

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Nabih I Abdou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Center for Rheumatic Disease, Allergy and Immunology

Locations

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The Center for Rheumatic Disease, Allergy and Immunology

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nabih I Abdou, MD, PhD.

Role: CONTACT

[email protected]
816-531-0930

Cindy Greenwell, RN

Role: CONTACT

[email protected]
816-531-0930

Facility Contacts

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Nabih I Abdou, MD, PhD

Role: primary

[email protected]
816-531-0930

Cindy A Greenwell, RN

Role: backup

[email protected]
816-531-0930

Other Identifiers

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05-024

Identifier Type: -

Identifier Source: org_study_id