The objective of this study is to assess the effect of exogenous female hormones on disease activity and severity in patients with systemic lupus erythematosus (SLE), a disease which largely affects minority women. Oral contraceptives and estrogen replacement therapy (ERT), also known as hormone replacement therapy (HRT) are generally not prescribed due to the widely held view that they can activate SLE. However, this traditionally accepted practice is based only on the greater incidence of SLE in women than men, biologic abnormalities of estrogen metabolism, murine models of lupus, several reports of patients having disease flares while receiving exogenous hormones, and one retrospective study in patients with preexisting renal disease. In contrast, recent retrospective studies suggest that the rate of flare is not significantly increased in patients taking oral contraceptives or hormone replacement therapy. The preexisting data is insufficient to warrant the dismissal of a potentially important birth control option in a disease that predominantly affects women in their reproductive years without appreciably altering their fertility. Moreover, the use of synthetic estrogens to preserve fertility in patients taking cyclophosphamide, and the use of estrogens to prevent coronary artery disease and postmenopausal and steroid-induced osteoporosis are timely considerations.The approach to the clinical study is to have two arms to the study, one oral contraceptive arm and one hormone replacement arm. Within each arm, the subjects disease activity is assessed and subjects are placed into groups of inactive or active, stable disease activity. Each disease classification within the two arms will be randomized individually. Patients will continue taking the prescribed pills for 13 cycles (1 year) or until that have a severe flare of SLE, or a complication which would require withdrawal from the study.
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