Efficacy and Safety Study of XP12B in Women With Menorrhagia

Phase 3

Completed

• Conditions: Menorrhagia; Heavy Menstrual Bleeding
• Interventions: Drug: Placebo tablets; Drug: Tranexamic acid tablets

• Registration Number: NCT00386308
• Lead Sponsor: Ferring Pharmaceuticals

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 Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-06
• Study First Submitted QC: 2006-10-09
• Study First Posted: 2006-10-11
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-12-11
• Results First Submitted QC: 2010-02-01
• Results First Posted: 2010-02-22
• Status Verified: 2010-06
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

Inclusion Criteria

• Women with menorrhagia
• 18-49 years of age
• Regularly occurring menstrual periods

Exclusion Criteria

• History or presence of clinically significant disease or abnormalities that may confound the study
• History of bilateral oophorectomy or hysterectomy
• Hormone therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo tablets	-
1	Tranexamic acid tablets	-

Primary Outcome Measures

Name	Time	Method
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	Baseline MBL over 6 menstrual cycles	reduction of menstrual blood loss in mL

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding	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	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	Reduction from Baseline over 6 menstrual cycles	Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Menomonee Falls, Wisconsin, United States