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Retrospective Analysis Explores LYSTEDA®'s Ability to Reduce Sleep Interruptions in Women With Cyclic Heavy Menstrual Bleeding
Date:5/4/2011

160;Women were randomized to receive either 3.9 g/day of LYSTEDA or placebo for up to five days at the onset of HMB.  Women continued in treatment for six cycles.  Patients recorded sleep disturbances in diaries during each menstrual period.  

About LYSTEDA

LYSTEDA is the only oral non-hormonal and non-surgical prescription medicine FDA-approved specifically to treat HMB.  In the 6-cycle treatment study, LYSTEDA significantly reduced menstrual blood loss by 38% compared to 12% with placebo.  Patients experienced full clinical efficacy as early as the first menstrual cycle which was maintained throughout all cycles studied.  LYSTEDA also significantly reduced limitations on social, leisure and physical activities during a woman's cycle.  LYSTEDA tablets are taken only during the menstrual cycle for up to five days.  Long-term treatment with LYSTEDA has been shown to be safe and well-tolerated in more than 10,000 cycles studied.  

LYSTEDA tablets are indicated for the treatment of cyclic heavy menstrual bleeding.  Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.  LYSTEDA has not been studied in adolescents under age 18 with heavy menstrual bleeding.

Important Safety Information

LYSTEDA is contraindicated in women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion; or known hypersensitivity to tranexamic acid.

The risk of thrombotic and thromboembolic events may increase further when hormonal contraceptives are administered with LYSTEDA, especially in women who are obese or smoke cigarettes.  Women using hormonal contraception should use LYSTEDA only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event.  Do not use
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SOURCE Ferring Pharmaceuticals Inc.
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