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Safety Study of XP12B in Women With Menorrhagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00113568
Recruitment Status : Completed
First Posted : June 9, 2005
Results First Posted : January 20, 2010
Last Update Posted : June 15, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 8, 2005
First Posted Date  ICMJE June 9, 2005
Results First Submitted Date  ICMJE December 11, 2009
Results First Posted Date  ICMJE January 20, 2010
Last Update Posted Date June 15, 2010
Study Start Date  ICMJE June 2005
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Safety through 12 months
Change History Complete list of historical versions of study NCT00113568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Quality of life through 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of XP12B in Women With Menorrhagia
Official Title  ICMJE Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Menorrhagia
  • Heavy Menstrual Bleeding
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: XP12B (tranexamic acid tablets)
Intervention: Drug: Tranexamic acid tablets (XP12B)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2008)
784
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1071
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00113568
Other Study ID Numbers  ICMJE XP12B-MR-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Development Support, Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP