Estrogen and Gender Biased Autoimmunity
1 other identifier
observational
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 8, 2010
September 1, 2010
8.7 years
August 20, 2007
September 3, 2010
Conditions
Keywords
Study Arms (1)
Female Lupus patients
Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.
Interventions
100ml blood for analysis, taken no more than 4 times in one year.
Eligibility Criteria
Female subjects with SLE and still cycling, not on hormones, compared to normal controls, female subjects still cycling, also not on hormones and not diagnosed with SLE.
You may qualify if:
- female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.
You may not qualify if:
- Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Center for Rheumatic Disease, Allergy and Immunology
Kansas City, Missouri, 64111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nabih I Abdou, MD, PhD
The Center for Rheumatic Disease, Allergy and Immunology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 22, 2007
Study Start
April 1, 2005
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 8, 2010
Record last verified: 2010-09