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Trial NCT00000419

Resource URI: http://static.linkedct.org/resource/trials/NCT00000419
PropertyValue
linkedct:brief_title Safety of Estrogens in Lupus: Hormone Replacement Therapy
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5954>
linkedct:condition <http://static.linkedct.org/resource/condition/12793>
linkedct: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
linkedct: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
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 85 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date August 2002
linkedct:enrollment 350 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000419
rdfs:label Trial NCT00000419
linkedct:lastchanged_date January 3, 2007
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/152746>
linkedct:location <http://static.linkedct.org/resource/location/153292>
linkedct:location <http://static.linkedct.org/resource/location/154421>
linkedct:location <http://static.linkedct.org/resource/location/157869>
linkedct:location <http://static.linkedct.org/resource/location/160169>
linkedct:location <http://static.linkedct.org/resource/location/163037>
linkedct:location <http://static.linkedct.org/resource/location/164446>
linkedct:location <http://static.linkedct.org/resource/location/166641>
linkedct:location <http://static.linkedct.org/resource/location/177824>
linkedct:location <http://static.linkedct.org/resource/location/186474>
linkedct:location <http://static.linkedct.org/resource/location/188842>
linkedct:location <http://static.linkedct.org/resource/location/193129>
linkedct:location <http://static.linkedct.org/resource/location/198108>
linkedct:location <http://static.linkedct.org/resource/location/198934>
linkedct:location <http://static.linkedct.org/resource/location/202251>
linkedct:location <http://static.linkedct.org/resource/location/209810>
linkedct:nct_id NCT00000419
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy
linkedct:org_study_id U01 AR42540 NIAMS-028A
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/27811>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/41718>
linkedct:overall_status Terminated
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000419>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/52774>
linkedct:reference <http://static.linkedct.org/resource/reference/53754>
linkedct:reference <http://static.linkedct.org/resource/reference/5816>
linkedct:reference <http://static.linkedct.org/resource/reference/5817>
linkedct:reference <http://static.linkedct.org/resource/reference/602>
linkedct:reference <http://static.linkedct.org/resource/reference/8815>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4844>
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date April 1996
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 2002