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FDA approves Mirena for IUD users

The US FDA has approved Mirena to treat heavy menstrual bleeding in women who use intra-uterine contraception

The US Food and Drink Administration (FDA) has approved Mirena to treat heavy menstrual bleeding in women who use intra-uterine contraception.

Mirena (levonorgestrel intra-uterine system), by Bayer HealthCare, was approved as a contraceptive by the FDA in 2000 and is the first intra-uterine device to be approved by the FDA for this additional indication.

"In the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss," said Dr Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.

Participants in the clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some of the women.

Clinical studies to support both the contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant.

5th October 2009

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