Safety of Estrogens in Lupus: Birth Control Pills

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives

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 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.

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.

Overall Status Completed
Start Date 1997-06-01
Completion Date 2003-08-01
Phase Phase 3
Study Type Interventional
Enrollment 350
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ortho-Novum 777

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

39 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
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, Dept. of Medicine/Immunology | Shreveport, Louisiana, 71130-3932, United States
Johns Hopkins Hospital, Dept. of Rheumatology | Baltimore, Maryland, 21205, United States
Univ. of Michigan Med. Ctr., Rheumatology Division | Ann Arbor, Michigan, 48109-0358, United States
Albert Einstein College of Medicine, Jacobi 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, Dept. of Rheumatology | 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 | Richmond, Virginia, 23219, United States
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States
Location Countries

United States

Verification Date

2013-05-01

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Double

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