Levonorgestrel IUD Approved to Treat Heavy Menstrual Bleeding

Yael Waknine

October 02, 2009

October 2, 2009 — The US Food and Drug Administration (FDA) has approved a new indication for a levonorgestrel-releasing intrauterine device (IUD; Mirena, Bayer Healthcare Pharmaceuticals, Inc) for the treatment of heavy menstrual bleeding in women who choose an intrauterine contraception.

Heavy menstrual bleeding occurs in 9% to 14% of women and is characterized by the need to use double sanitary protection, menstrual flow that soaks through 1 or more sanitary pads/tampons per hour, and the need to change sanitary protection during the night.

"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Kathleen Uhl, MD, director of the FDA's Office of Women's Health in an agency news release. "Bleeding can be so heavy that women must miss work, school, or social activities."

The FDA approval was based on data from a randomized, open-label clinical trial that compared use of the IUD with medroxyprogesterone acetate in 160 women with heavy menstrual bleeding, defined as menstrual blood loss of 80 mL or greater. The study excluded women having conditions that cause heavy bleeding, with the exception of fibroids (total volume ≤ 5 mL).

Results showed that 85% of women using the IUD achieved a 50% or greater decrease in menstrual blood loss from baseline compared with 22% of those receiving medroxyprogesterone acetate (P < .001).

Adverse events most commonly reported with use of the IUD included intrauterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, dysmenorrhea, pelvic pain, and breast tenderness.

The levonorgestrel-releasing IUD previously was approved for contraceptive use in women who have had a child; clinical studies for both indications have excluded women with no history of pregnancy.


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