Clinical Trial: Efficacy and Safety Study of XP12B in Women With Menorrhagia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia

Brief Summary: The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) [ Time Frame: Baseline MBL over 6 menstrual cycles ]

reduction of menstrual blood loss in mL


Original Primary Outcome: Efficacy of XP12B to reduce menstrual blood loss in women with objective evidence of heavy menstrual bleeding.

Current Secondary Outcome:

  • Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Change from Baseline scores over 6 menstrual cycles ]
    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
  • Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Change from Baseline scores over 6 menstrual cycles ]
    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
  • Responder Analysis - Reduction in Large Stains [ Time Frame: Reduction from Baseline over 6 menstrual cycles ]
    Percentage of subjects who experienced a reduction from baseline in the frequency of large stains


Original Secondary Outcome: Safety and patient reported outcome improvements

Information By: Ferring Pharmaceuticals

Dates:
Date Received: October 6, 2006
Date Started: October 2006
Date Completion:
Last Updated: May 3, 2011
Last Verified: June 2010