Safety of Estrogens in Lupus: Birth Control Pills
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Ortho-Novum 777
Intervention type(s): Drug
Intervention MeSH terms: Norinyl
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: SLE; SELENA; Oral contraceptives; The pill; Birth control; Condom; Diaphragm; Estrogen; Lupus; Placebo