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.

Condition	Treatment or Intervention	Phase
Systemic Lupus Erythematosus	Drug: Premarin and Provera	Phase III

Further Study Details: 

Expected Total Enrollment:  350

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

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Female

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

Alabama
      UAB Medical Center, Birmingham,  Alabama,  35294,  United States
California
      UCLA Medical Center, Dept. of Rheumatology, Los Angeles,  California,  90024,  United States
Illinois
      University of Chicago Pritzker School of Medicine, Chicago,  Illinois,  60637,  United States
Louisiana
      Louisiana School of Medicine, Shreveport,  Louisiana,  71130-3932,  United States
Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21205,  United States
Michigan
      Univ. of Michigan Med. Ctr., Rheumatology Div., Ann Arbor,  Michigan,  48109-0358,  United States
New York
      Hospital for Joint Diseases, New York,  New York,  10003,  United States
      Hospital for Special Surgery, New York,  New York,  10021,  United States
      Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology, Bronx,  New York,  10461,  United States
North Carolina
      UNC Medical Center, Dept. of Rheumatology, Chapel Hill,  North Carolina,  27599-7280,  United States
Oklahoma
      Oklahoma Medical Research Foundation, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Univ. of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104,  United States
      Univ. of Pittsburgh, Dept. of Rheumatology, Pittsburgh,  Pennsylvania,  15213,  United States
Texas
      University of Texas Health Sciences Center, Houston,  Texas,  77030,  United States
Virginia
      Medical College of Virginia, Ambulatory Care Center, Richmond,  Virginia,  23219,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

Study chairs or principal investigators

Jill Buyon, M.D.,  Principal Investigator,  Hospital for Joint Diseases, Department of Rheumatology   
Michelle Petri, M.D.,  Study Director,  Johns Hopkins Hospital, Department of Rheumatology   

Study ID Numbers:  NIAMS-028A; U01 AR42540
Record last reviewed:  October 2002
Last Updated:  November 3, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00000419
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08