Safety Study of XP12B in Women With Menorrhagia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113568

Enrollment

784

Registered

2005-06-09

Start date

2005-06-30

Completion date

2009-05-31

Last updated

2010-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Menstrual Bleeding, Menorrhagia

Keywords

Menorrhagia, Heavy Menstrual Bleeding

Brief summary

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Interventions

DRUGTranexamic acid tablets (XP12B)

Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Adverse Events That Led to Discontinuation From the Study	Up to 27 menstrual cycles	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
Number of Subjects With at Least One Adverse Event During the Study	Up to 27 menstrual cycles	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.
Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study	Up to 27 menstrual cycles	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.
Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study	Up to 27 menstrual cycles	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.
Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study	Up to 27 menstrual cycles	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.
Number of Subjects With at Least One Serious Adverse Event During the Study	Up to 27 menstrual cycles	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.
Number of Subjects With at Least One Life-Threatening Adverse Event During the Study	Up to 27 menstrual cycles	A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.
Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study	Up to 27 menstrual cycles	Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.
Number of Subjects Who Died During the Study	Up to 27 menstrual cycles	Number of subjects who died, for any reason, during the study

Countries

United States

Participant flow

Participants by arm

Arm	Count
Tranexamic Acid Tablets (XP12B) Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation	723
Total	723

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	97
Overall Study	Death	1
Overall Study	Lack of Efficacy	30
Overall Study	Lost to Follow-up	156
Overall Study	Other	112
Overall Study	Protocol Violation	32
Overall Study	Withdrawal by Subject	117

Baseline characteristics

Characteristic	Tranexamic Acid Tablets (XP12B)
Age Continuous	38 years STANDARD_DEVIATION 7
Sex: Female, Male Female	723 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	678 / 723
serious Total, serious adverse events	28 / 723