Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

Inclusion criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Established systemic lupus erythematosus meeting American College of Rheumatology criteria Inactive disease Systemic Lupus Erythematosus Activity Index (SLEDAI) score no greater than 4 No increase in score of more than 2 from baseline over the past 3 months Receiving the equivalent of 5 mg or less of prednisone per day OR Stable/active disease SLEDAI score 5-12 No increase in score of more than 2 from baseline over the past 3 months Prednisone dose up to 0.5 mg/kg/day for control of underlying disease allowed if stable dose for at least 3 weeks No concurrent severe disease activity as defined by any of the following: * Acute renal disease (i.e., rising creatinine levels, cellular sediment, or increasing proteinuria) * Involvement of 3 or more organ systems requiring more than the equivalent of 0.5 mg/kg/day of prednisone * Necessity of immediate hospitalization for symptom control No presence of a high titer IgG, IgM, or IgA antiphospholipid antibodies (aPL) GPL and MPL no more than 40 APL no more than 50 No features of primary antiphospholipid antibody syndrome --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Prior hysterectomy allowed --Patient Characteristics-- Age: 35 and under for oral contraceptive stratum (premenopausal) 50 and over for hormone replacement therapy stratum (postmenopausal) Menopausal status: * Premenopausal for oral contraceptive stratum * Postmenopausal for hormone replacement therapy stratum * Follicle-stimulating hormone greater than 40 mIU/mL OR Amenorrhea for 6 months Performance status: See Disease Characteristics Hematopoietic: Not specified Hepatic: * No hepatic dysfunction * No tumors of the liver Renal: See Disease Characteristics Cardiovascular: * No uncontrolled high blood pressure requiring frequent change in medication * Concurrent hypertension controlled with stable medication allowed * No history of spontaneous superficial or deep venous thrombosis or arterial thrombosis * No prior myocardial infarction * Oral contraceptive stratum: No angina No diastolic blood pressure greater than 90 mm Hg or systolic blood pressure greater than 140 mm Hg on 3 separate determinations * Hormone replacement therapy stratum: No diastolic blood pressure greater than 95 mm Hg or systolic blood pressure greater than 145 mm Hg on 3 separate determinations Pulmonary: No history of pulmonary embolus Other: * Not pregnant * Oral contraceptive stratum: Negative pregnancy test Fertile patients must use effective barrier contraception * No prior gynecologic malignancy or breast malignancy * No undiagnosed vaginal bleeding * No diabetes (present prior to use of glucocorticoids) requiring oral hypoglycemic medications or insulin * No congenital hyperlipidemia * No complicated migraines (i.e., associated with neurological sequelae)