Safety of Estrogens in Lupus: Birth Control Pills

Launched by NYU LANGONE HEALTH · Nov 3, 1999

Keywords

ClinConnect Summary

This study tests the effect of exogenous female hormones on disease activity and severity in women with systemic lupus erythematosus (SLE). Physicians generally do not prescribe oral contraceptives (OCs) to women with lupus because of the widely held view that these drugs can activate SLE. This practice is based on the greater incidence of SLE in women than in men, biologic abnormalities of estrogen metabolism, murine models of lupus, several anecdotes of patients having disease flares while receiving exogenous hormones, and a single retrospective study in patients with preexisting renal di...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • Unequivocal diagnosis of SLE
• • Inactive disease or be stable on 0.5 mg/kg/day or less of predisone
• • Must be between 18 and 39 years old if non-smoker
• • Must be between 18 and 35 years old if smoker
• Exclusion Criteria:
• • Blood pressure \>145/95 on three occasions
• • Deep vein, arterial thrombosis or pulmonary embolus
• • GPL \>40; MPL \>40; APL \>50; dRVVT \>37 sec
• • APL antibody syndrome ever
• • Gynecologic or breast cancer
• • Hepatic dysfunction or liver tumors
• • Diabetes mellitus (NOT due to steroids) with vascular disease
• • Congenital hyperlipidemia
• • Complicated migraine
• • Severe disease activity (SLEDAI \>12)
• • Increase in SLEDAI \>2 points in 3 months
• • Unexplained vaginal bleeding
• • Use of estrogen (OCP) for \>1 month at any time after SLE diagnosis
• • Present pregnancy
• • Angina or MI due to APS
• • Age \>35 yrs. for smokers; \>39 yrs. for nonsmokers