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Safety of Estrogens in Lupus: Birth Control Pills

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ClinicalTrials.gov Identifier: NCT00000420
Recruitment Status : Completed
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 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 or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Ortho-Novum 777 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 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.

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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): Oral Contraceptives
Study Start Date : June 1997
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Binovum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female
  • Unequivocal diagnosis of SLE
  • Inactive disease or be stable on 0.5 mg/kg/day or less of predisone
  • Must be between 18 and 39 years old if non-smoker
  • Must be between 18 and 35 years old if smoker

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 (OCP) for >1 month at any time after SLE diagnosis
  • Present pregnancy
  • Angina or MI due to APS
  • Age >35 yrs. for smokers; >39 yrs. for nonsmokers

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): NCT00000420

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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
Albert Einstein College of Medicine, Jacobi 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, Dept. of Rheumatology
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
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 P. Buyon, MD Hospital for Joint Diseases
Study Director: Michelle Petri, MD Johns Hopkins University Hospital, Dept. of Rheumatology
Publications of Results:
Other Publications:
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ClinicalTrials.gov Identifier: NCT00000420    
Other Study ID Numbers: U01 AR42540 NIAMS-028B
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:
Oral contraceptives
The pill
Birth control
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Hormonal
Contraceptive Agents, Hormonal