A trial of contraceptive methods in women with systemic lupus erythematosus.

Background The effects of estrogen-containing contraceptives on disease activity in women with systemic lupus erythematosus have not been determined. Methods We conducted a single-blind clinical trial involving 162 women with systemic lupus erythematosus who were randomly assigned to combined oral contraceptives, a progestin-only pill, or a copper intrauterine device (IUD). Disease activity was assessed at 0, 1, 2, 3, 6, 9, and 12 months according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). The primary outcome was global disease activity, which we estimated by measuring the area under the SLEDAI curve. Secondary outcomes included the maximum SLEDAI score, change in SLEDAI score, incidence of lupus flares, median time to first flare, systemic lupus erythematosus treatment, and adverse events. The results were analyzed by the intention-to-treat method. Results At baseline, all demographic features and disease characteristics were similar in the three groups. The mean (±SD) SLEDAI sc...