Safety of Estrogens in Lupus: Hormone Replacement Therapy

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 hormone replacement therapy (HRT) to women with SLE because of the widely held view that such treatment 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...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • Unequivocal diagnosis of SLE
• • Inactive disease or stable on 0.5 mg/kg/day or less of prednisone
• • Chemical evidence of menopause or have stopped periods for at least 6 months
• 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 (HRT or OCP) for \>1 month at any time after SLE diagnosis
• • FSH \<40
• • Premenopausal myocardial infarction

Trial Officials