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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: | NCT00000420 |
Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: Ortho-Novum 777 |
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): Oral Contraceptives |
Estimated Enrollment: | 350 |
Study Start Date: | June 1997 |
Estimated Study Completion Date: | August 2003 |
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 oral contraceptives (OCs) to women with lupus because of the widely held view that these drugs 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 OCs. The preexisting data is insufficient to warrant the dismissal of a potentially important birth control option in a disease that predominantly affects women in their reproductive years and whose fertility is not altered by the disease. Moreover, the use of OCs to preserve fertility in patients taking cyclophosphamide and the use of estrogens to prevent coronary artery disease and postmenopausal and steroid-induced osteoporosis are timely considerations.
We will attempt to define, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of OCs containing low-dose synthetic estrogens and progestins on disease activity in women with SLE. Because the research hypothesis is that OCs do not increase the risk of flares, we have designed the study to be able to detect minimal increases in the rate of flares in patients taking OCs.
We will enroll patients with inactive, stable, or moderate disease requiring less than 0.5 mg prednisone per kg of bodyweight per day over a 2-year period and randomize them to receive birth control pills or placebo pills for 12 months. During that time, the patient must use condoms or a diaphragm as birth control. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.
Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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, Dept. of Medicine/Immunology | |
Shreveport, Louisiana, United States, 71130-3932 | |
United States, Maryland | |
Johns Hopkins Hospital, Dept. of Rheumatology | |
Baltimore, Maryland, United States, 21205 | |
United States, Michigan | |
Univ. of Michigan Med. Ctr., Rheumatology Division | |
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, Dept. of Rheumatology | |
New York, New York, United States, 10021 | |
Albert Einstein College of Medicine, Jacobi 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 | |
Richmond, Virginia, United States, 23219 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Jill P. Buyon, MD | Hospital for Joint Diseases |
Study Director: | Michelle Petri, MD | Johns Hopkins University Hospital, Dept. of Rheumatology |
Study ID Numbers: | U01 AR42540 NIAMS-028B |
Study First Received: | November 3, 1999 |
Last Updated: | January 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00000420 |
Health Authority: | United States: Federal Government |
SLE SELENA Oral contraceptives The pill Birth control |
Condom Diaphragm Estrogen Lupus Placebo |
Modicon Autoimmune Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Norinyl |
Contraceptives, Oral, Combined Immune System Diseases Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs |
Contraceptives, Oral Contraceptive Agents, Female Reproductive Control Agents Pharmacologic Actions |