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Clinical Data Demonstrates That LYSTEDA™ Significantly Reduced Menstrual Blood Loss and Limitations on Social, Leisure and Physical Activities in Women With Cyclic HMB
Date:5/19/2010

A Meaningful Reduction in MBL

To quantify 'meaningful' reduction in MBL in women with HMB after treatment with LYSTEDA, data from 294 women in the study were used in a blinded receiver operating characteristic (ROC) analysis.  MBL was measured in two ways during the study.  One measured the blood loss using a validated alkaline hematin method at baseline and after treatment with LYSTEDA. The second measured a meaningful reduction in MBL using the Menorrhagia Impact Questionnaire (MIQ), a patient-reported outcome instrument previously validated in an HMB population.  Women in this study were asked if the change in their period after treatment was 'meaningful or important' after treatment compared to their prior pretreatment cycles.  After treatment with LYSTEDA, women with HMB perceived an MBL reduction of 36 mL or greater to be meaningful.  

Effect of LYSTEDA Treatment on Social, Leisure and Physical Activities

To measure changes in social, leisure and physical activities in women with HMB treated with LYSTEDA, women (n=294) were randomized (2:2:1) to receive LYSTEDA 1.95 g/day (n=115), LYSTEDA 3.9 g/day (n=112), or placebo (n=67) for up to five days per menstrual period for three cycles.  The MIQ was used to measure changes at baseline and after three treatment menstrual cycles.  The questionnaire contains questions about limitations on social, leisure, physical, or work activities during menstruation, and the woman's perception of the influence of MBL on those measures.  Women receiving either dose of LYSTEDA experienced significant improvements in all measurements from baseline compared with placebo (P <.01 for each dose).  Improvement in all measurements was greater in women receiving high-dose LYSTEDA compared with low-dose LYSTEDA.  Both dosage regimens were
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SOURCE Ferring Pharmaceuticals Inc.
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