Systemic Lupus Erythematosus
Conditions
Keywords
SLE, SELENA, Estrogen Replacement Therapy (ERT), Postmenopause, Osteoporosis, Estrogens, Steroids, Progestin, Placebo
Brief summary
Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.
Detailed description
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 renal disease. By contrast, recent retrospective studies suggest that the rate of flare is not significantly increased in patients taking HRT. We will examine, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of hormonal replacement with conjugated estrogens on disease activity in postmenopausal women with SLE. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups. We will give patients hormones for 1 year. NOTE: This trial has been terminated as of August 2002 upon recommendation of the Data Safety Monitoring Board (DSMB), based on the findings of the WHI Trial. Study subjects have discontinued study drug but will continue followup visits to study doctors through May 2003
Interventions
DRUGPremarin and Provera
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed