Efficacy and Safety Study of XP12B in Women With Menorrhagia

Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding

A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited

Time frame: Change from Baseline scores over 6 menstrual cycles

Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding

A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited

Time frame: Change from Baseline scores over 6 menstrual cycles

Responder Analysis - Reduction in Large Stains

Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

Time frame: Reduction from Baseline over 6 menstrual cycles