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

You may be eligible if

• 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)