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Home > "S" Clinical Trials Conditions > Safety of Estrogens in Lupus: Birth Control Pills  Safety of Estrogens in Lupus: Birth Control Pills
Safety of Estrogens in Lupus: Birth Control Pills
For Condition: Systemic Lupus Erythematosus
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) , Office of Research on Women's Health (ORWH)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/39 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 350
Location and Contact Information:
Overall Study Official:
JillBuyon, Principal Investigator, Hospital for Joint Diseases
Albert Einstein College of Medicine, Jacobi Hospital, Dept. of Rheumatology
Bronx, New York, 10461
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Johns Hopkins Hospital, Dept. of Rheumatology
Baltimore, Maryland, 21205
United States
Univ. of Pittsburgh, Dept. of Rheumatology
Pittsburgh, Pennsylvania, 15213
United States
Medical College of Virginia
Richmond, Virginia, 23219
United States
Louisiana School of Medicine, Dept. of Medicine/Immunology
Shreveport, Louisiana, 71130-3932
United States
Univ. of Michigan Med. Ctr., Rheumatology Division
Ann Arbor, Michigan, 48109-0358
United States
University of Texas Health Sciences Center
Houston, Texas, 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
UNC Medical Center, Dept. of Rheumatology
Chapel Hill, North Carolina, 27599-7280
United States
Hospital for Special Surgery, Dept. of Rheumatology
New York City, New York, 10021
United States
Hospital for Joint Diseases
New York City, New York, 10003
United States
University of Chicago Pritzker School of Medicine
Chicago, Illinois, 60637
United States
UCLA Medical Center, Dept. of Rheumatology
Los Angeles, California, 90024
United States
Univ. of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: NIAMS-028B; U01 AR42540
Study Start Date: June 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000420
Other Systemic Lupus Erythematosus Studies:
1. Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus
2. Drug Therapy in Lupus Nephropathy
3. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
4. Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
5. Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus
Related Studies:
Other Systemic Lupus Erythematosus Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Safety of Estrogens in Lupus: Birth Control Pills
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