Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy

Safety of Estrogens in Lupus: Hormone Replacement Therapy

Sponsors

Lead sponsor: NYU Langone Health

Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)

Source NYU Langone Health
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

Overall Status Terminated
Start Date April 1996
Completion Date August 2002
Phase Phase 3
Study Type Interventional
Enrollment 350
Condition
Intervention

Intervention type: Drug

Intervention name: Premarin and Provera

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

Gender: Female

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

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

United States

Verification Date

May 2013

Keywords
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov