The overall goal of the current study is to address 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 are generally not prescribed due to the practice is based only on the predominance of female gender, biologic abnormalities of estrogen metabolism, murine models of lupus, several anecdotes of patients having disease flares while receiving exogenous hormones, and one retrospective study in patients with pre-existing renal disease. In contrast, a more recent retrospective study suggests that the rate of flare is not statistically increased in patients taking oral contraceptives. The pre-existing data are insufficient to warrant the dismissal of a potentially important birth control option in a disease which predominantly affects women in their reporductive years and whose fertility is not appreciably altered by the disease. Moreover, the use of synthetic estrogens to preserve fertility in patients taking cyclophosphamide and the use of estrogens to prevent post-menopausal and steroid induced osteoporosis are timely considerations. Women with lupus who are fertile who choose to participate will be randomly divided into a group that takes birth control pills (oral contraceptives) and a group that does not. The women and their doctors will not know what grouop they are in, because both groups will take tablets that appear identical. Women with high blood pressure, a history of a blood clot, lupus antibodies that cause clot, cancer, heart disease, liver disease, diabetes, complicated migraines, and very active lupus cannot participate.
NIH ExPorter
NIH ExPorter