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Estrogen and Gender Biased Autoimmunity

Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00519454
Enrollment
75
Registered
2007-08-22
Start date
2005-04-30
Completion date
2013-12-31
Last updated
2010-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, Estrogen receptors, T cells, Hormones, Female adult SLE

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.

Interventions

OTHERPeripheral lab draws

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

Sponsors

AstraZeneca
CollaboratorINDUSTRY
The Center for Rheumatic Disease, Allergy, & Immunology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Countries

United States

Contacts

Primary ContactNabih I Abdou, MD, PhD.
niabdou@centerforrheumatic.com816-531-0930
Backup ContactCindy Greenwell, RN
cindy@centerforrheumatic.com816-531-0930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026