A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

This study has been completed.
Sponsor:
Collaborator:
Xanodyne Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01280981
First received: January 19, 2011
Last updated: June 28, 2011
Last verified: June 2011
Results First Received: May 3, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Menorrhagia
Intervention: Drug: Tranexamic acid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed double-blind therapy in either study XP12B-MR-301 (NCT00401193) or XP12B-MR-303 (NCT00386308) could participate in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tranexamic Acid Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).

Participant Flow:   Overall Study
    Tranexamic Acid  
STARTED     288  
Intent to Treat (ITT) Population     260 [1]
COMPLETED     196  
NOT COMPLETED     92  
Withdrawal by Subject                 11  
Protocol Violation                 2  
Lack of Efficacy                 13  
Lost to Follow-up                 3  
Adverse Event                 6  
Irregular or discontinued menses                 3  
Failed to return                 45  
Non-compliance with protocol                 3  
Withdrawal of consent                 3  
Elective surgery                 2  
Study site closure                 1  
[1] Participants who took drug during at least one menstrual cycle



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tranexamic Acid Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).

Baseline Measures
    Tranexamic Acid  
Number of Participants  
[units: participants]
  288  
Age  
[units: participant]
 
<=18 years     0  
Between 18 and 65 years     288  
>=65 years     0  
Gender  
[units: participants]
 
Female     288  
Male     0  



  Outcome Measures
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1.  Primary:   Participants With Treatment-Emergent Adverse Events (AEs)   [ Time Frame: Day 1 to up to Month 9 ]

2.  Secondary:   Participants With Abnormal Gynecological Examinations   [ Time Frame: Day 1 to up to Month 9 ]

3.  Secondary:   Mean Blood Pressure Measurements at Week 36   [ Time Frame: approximately week 36 ]

4.  Secondary:   Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment   [ Time Frame: Day 1 to up to Month 9 ]

5.  Secondary:   Mean Intraocular Pressure at Month 9   [ Time Frame: Day 1 up to Month 9 ]

6.  Secondary:   Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9   [ Time Frame: Month 9 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com


No publications provided


Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01280981     History of Changes
Other Study ID Numbers: XP12B-MR-304
Study First Received: January 19, 2011
Results First Received: May 3, 2011
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration