Safety Study of XP12B in Women With Menorrhagia

Phase 3

Completed

• Conditions: Menorrhagia; Heavy Menstrual Bleeding
• Interventions: Drug: Tranexamic acid tablets (XP12B)

• Registration Number: NCT00113568
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-08
• Study First Submitted QC: 2005-06-08
• Study First Posted: 2005-06-09
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2009-12-11
• Results First Submitted QC: 2009-12-11
• Results First Posted: 2010-01-20
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 784

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XP12B (tranexamic acid tablets)	Tranexamic acid tablets (XP12B)	-

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Tacoma, Washington, United States