Estrogen and Gender Biased Autoimmunity

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00519454
• Lead Sponsor: The Center for Rheumatic Disease, Allergy, & Immunology

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-03
• Last Update Posted: 2010-09-08
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

The Center for Rheumatic Disease, Allergy and Immunology; 🇺🇸 Kansas City, Missouri, United States