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Safety Study of XP12B in Women With Menorrhagia

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00113568
First received: June 8, 2005
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Menorrhagia
Heavy Menstrual Bleeding
Drug: Tranexamic acid tablets (XP12B)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects With at Least One Adverse Event During the Study [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 27 menstrual cycles ] [ Designated as safety issue: Yes ]
    Number of subjects who died, for any reason, during the study


Enrollment: 784
Study Start Date: June 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XP12B (tranexamic acid tablets) Drug: Tranexamic 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
Other Names:
  • Lysteda
  • XP12B
  • tranexamic acid tablets
  • XP12B-MR

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113568

  Show 59 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00113568     History of Changes
Other Study ID Numbers: XP12B-MR-302
Study First Received: June 8, 2005
Results First Received: December 11, 2009
Last Updated: June 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Menorrhagia
Heavy Menstrual Bleeding

Additional relevant MeSH terms:
Hemorrhage
Menorrhagia
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014