Safety Study 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 evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Official Title
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Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

Conditions
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Menorrhagia, Heavy Menstrual Bleeding

Intervention / Treatment
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* Drug: Tranexamic acid tablets (XP12B)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with menorrhagia 18-49 years of age Regularly occuring menstrual periods Exclusion Criteria: History or presence of clinically significant disease or abnormalities that might confound the study History of bilateral oophorectomy or hysterectomy

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XP12B (tranexamic acid tablets)<br> | Drug: Tranexamic acid tablets (XP12B)<br>* Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation<br>* Other names: XP12B-MR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Adverse Event During the Study | An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship. | Up to 27 menstrual cycles | 
| Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies. | Up to 27 menstrual cycles | 
| Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies. | Up to 27 menstrual cycles | 
| Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug. | Up to 27 menstrual cycles | 
| Number of Subjects With at Least One Serious Adverse Event During the Study | A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment. | Up to 27 menstrual cycles | 
| Number of Subjects With at Least One Life-Threatening Adverse Event During the Study | A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred. | Up to 27 menstrual cycles | 
| Number of Subjects With Adverse Events That Led to Discontinuation From the Study | The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator | Up to 27 menstrual cycles | 
| Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study | Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction. | Up to 27 menstrual cycles | 
| Number of Subjects Who Died During the Study | Number of subjects who died, for any reason, during the study | Up to 27 menstrual cycles | 

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