FDA Approves Intrauterine Device for Heavy Menstrual Bleeding

The FDA approved the levonorgestrel intrauterine system (Mirena) for treatment of excessive menstrual bleeding in women who use intrauterine contraception, the agency announced. The device was first marketed in 2000 for contraception in women who already have had a child.

The new indication was approved following a clinical trial of 160 women with confirmed heavy menstrual bleeding, the manufacturer said. After six menstrual cycles, Mirena was found to be more effective than medroxyprogesterone acetate in reducing monthly blood loss to less than 80 mL and by more than 50% from baseline.

Common side effects in the trial included uterine bleeding or spotting, headache, ovarian cysts, vaginitis, pelvic pain, dysmenorrhea, and breast tenderness.