Efficacy and Safety of XP12B in Women With Menorrhagia

Study Overview
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Brief Summary
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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.

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

Conditions
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Menorrhagia, Heavy Menstrual Bleeding

Intervention / Treatment
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* Drug: Tranexamic acid tablets
* Drug: Tranexamic acid tablets
* Drug: Placebo tablets


Participation Criteria
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Eligibility Criteria
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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 for birth control

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Tranexamic acid tablets<br>* 3900 mg/Day<br>* Other names: XP12B;|
| Experimental: 2<br> | Drug: Tranexamic acid tablets<br>* 1950 mg/Day<br>* Other names: XP12B;|
| Placebo Comparator: 3<br> | Drug: Placebo tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | reduction of menstrual blood loss in mL | Baseline MBL over 3 menstrual cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the 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 | Baseline scores over 3 menstrual cycles | 
| Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the 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 | Baseline scores over 3 menstrual cycles | 
| Responder Analysis - Reduction in Large Stains | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains | Baseline over 3 mentrual cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menorrhagia, Heavy Menstrual Bleeding