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Safety of Estrogens in Lupus: Hormone Replacement Therapy

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ClinicalTrials.gov Identifier: NCT00000419
Recruitment Status : Terminated
First Posted : November 4, 1999
Last Update Posted : May 3, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Premarin and Provera Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy
Study Start Date : April 1996
Study Completion Date : August 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000419

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United States, Alabama
UAB Medical Center
Birmingham, Alabama, United States, 35294
United States, California
UCLA Medical Center, Dept. of Rheumatology
Los Angeles, California, United States, 90024
United States, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois, United States, 60637
United States, Louisiana
Louisiana School of Medicine
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Michigan
Univ. of Michigan Med. Ctr., Rheumatology Div.
Ann Arbor, Michigan, United States, 48109-0358
United States, New York
Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology
Bronx, New York, United States, 10461
Hospital for Joint Diseases
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
UNC Medical Center, Dept. of Rheumatology
Chapel Hill, North Carolina, United States, 27599-7280
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Univ. of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Univ. of Pittsburgh, Dept. of Rheumatology
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Health Sciences Center
Houston, Texas, United States, 77030
United States, Virginia
Medical College of Virginia, Ambulatory Care Center
Richmond, Virginia, United States, 23219
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
NYU Langone Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Research on Women's Health (ORWH)
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Principal Investigator: Jill Buyon, M.D. Hospital for Joint Diseases, Department of Rheumatology
Study Director: Michelle Petri, M.D. Johns Hopkins Hospital, Department of Rheumatology
Publications of Results:
Other Publications:
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ClinicalTrials.gov Identifier: NCT00000419    
Other Study ID Numbers: U01 AR42540 NIAMS-028A
U01AR042540 ( U.S. NIH Grant/Contract )
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013
Keywords provided by NYU Langone Health:
Estrogen Replacement Therapy (ERT)
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Medroxyprogesterone Acetate
Estrogens, Conjugated (USP)
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists