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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

WASHINGTON, May 4, 2011 /PRNewswire/ -- Cyclic heavy menstrual bleeding (HMB) has been reported to significantly impact a woman's ability to get uninterrupted sleep which can often lead to daytime fatigue and irritability.(1)  According to a recent retrospective analysis of the 6-cycle pivotal trial that supported product approval, women taking LYSTEDA® (tranexamic acid) Tablets, 3.9 g/day, experienced a 0.99 mean reduction in the number of sleep interruptions over baseline (1.65) compared with a 0.70 mean reduction over baseline (1.92) for women in the placebo group (P=.0024).  LYSTEDA is a non-hormonal and non-surgical therapy specifically indicated for women with heavy menstrual bleeding that is taken only during menstruation.

The findings of the LYSTEDA study were presented in a poster at The American College of Obstetricians and Gynecologists' 59th Annual Clinical Meeting in Washington, DC, April 30 - May 4, 2011.  

"Women who experience heavy menstrual bleeding often present to a healthcare provider because of the subsequent negative impact on their daily lives and activities,"

said Ken Muse, MD, lead study investigator and Associate Professor of Obstetrics and Gynecology, University of Kentucky.  "Sleep interruptions caused by waking in the night to change sanitary products are often an under-recognized consequence of cyclic heavy menstrual bleeding."

According to the investigators, LYSTEDA was generally well tolerated with adverse events in the trial similar to placebo.  LYSTEDA is a non-hormonal prescription medication for HMB which has been shown to be effective in reducing menstrual blood loss beginning as early as the first cycle of treatment and which can be comfortably taken long term.

About the Study

This was a retrospective analysis of the randomized, placebo-controlled, parallel group study which was conducted in 187 women (18-49 years old) with cyclic HMB. &#
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SOURCE Ferring Pharmaceuticals Inc.
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