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)