Safety of Estrogens in Lupus: Birth Control Pills

Completed · Phase 3

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT00000420

Run by

NYU Langone Health

People needed

350

Starts

1997-06-01

Expected to finish

2003-08-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center, Dept. of Rheumatology — Los Angeles, California, United States
• University of Chicago Pritzker School of Medicine — Chicago, Illinois, United States
• Louisiana School of Medicine, Dept. of Medicine/Immunology — Shreveport, Louisiana, United States
• Johns Hopkins Hospital, Dept. of Rheumatology — Baltimore, Maryland, United States
• Univ. of Michigan Med. Ctr., Rheumatology Division — Ann Arbor, Michigan, United States
• Hospital for Joint Diseases — New York, New York, United States
• Hospital for Special Surgery, Dept. of Rheumatology — New York, New York, United States
• Albert Einstein College of Medicine, Jacobi Hospital, Dept. of Rheumatology — The Bronx, New York, United States
• UNC Medical Center, Dept. of Rheumatology — Chapel Hill, North Carolina, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Univ. of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Univ. of Pittsburgh, Dept. of Rheumatology — Pittsburgh, Pennsylvania, United States
• University of Texas Health Sciences Center — Houston, Texas, United States
• Medical College of Virginia — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.