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Completed

NCT Number: NCT00113568

Safety Study of XP12B in Women With Menorrhagia

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

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heavy Menstrual Bleeding Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic acid tablets (XP12B)

Drug

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

Primary outcomes

  1. Number of Subjects With at Least One Adverse Event During the Study

    Time frame: 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.

  2. Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study

    Time frame: 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.

  3. Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study

    Time frame: 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.

  4. Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study

    Time frame: 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.

  5. Number of Subjects With at Least One Serious Adverse Event During the Study

    Time frame: 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.

  6. Number of Subjects With at Least One Life-Threatening Adverse Event During the Study

    Time frame: 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.

  7. Number of Subjects With Adverse Events That Led to Discontinuation From the Study

    Time frame: 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

  8. Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study

    Time frame: Up to 27 menstrual cycles

    Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.

  9. Number of Subjects Who Died During the Study

    Time frame: Up to 27 menstrual cycles

    Number of subjects who died, for any reason, during the study

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 9, 2005
Registry last updated
Jun 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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