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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Office of Research on Women's Health (ORWH) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00000419 |
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 | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: Premarin and Provera |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy |
Estimated Enrollment: | 350 |
Study Start Date: | April 1996 |
Estimated Study Completion Date: | August 2002 |
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 to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Hospital for Joint Diseases | |
New York, New York, United States, 10003 | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
Albert Einstein College of Medicine, Jacoby Hospital, Dept. of Rheumatology | |
Bronx, New York, United States, 10461 | |
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 |
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 |
Study ID Numbers: | U01 AR42540 NIAMS-028A |
Study First Received: | November 3, 1999 |
Last Updated: | January 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00000419 |
Health Authority: | United States: Food and Drug Administration |
SLE SELENA Estrogen Replacement Therapy (ERT) Postmenopause Osteoporosis |
Estrogens Steroids Progestin Placebo |
Estrogens, Conjugated (USP) Medroxyprogesterone 17-Acetate Autoimmune Diseases Lupus Erythematosus, Systemic |
Connective Tissue Diseases Osteoporosis Medroxyprogesterone |
Immune System Diseases |