Estrogen and Gender Biased Autoimmunity

The Center for Rheumatic Disease, Allergy, & Immunology

Status: Unknown

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Peripheral lab draws

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00519454

05-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

75 participants in 1 patient group

Female Lupus patients

Description:

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

Treatment:

Other: Peripheral lab draws