Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 350
- Locations
- 30
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Premenopausal myocardial infarction