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Efficacy and Safety of XP12B in Women With Menorrhagia

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00401193
First received: November 9, 2006
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
Results First Received: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Menorrhagia
Heavy Menstrual Bleeding
Interventions: Drug: Tranexamic acid tablets
Drug: Placebo tablets

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
3900 mg/Day Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1950 mg/Day One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
Placebo Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation

Participant Flow:   Overall Study
    3900 mg/Day     1950 mg/Day     Placebo  
STARTED     118     117     69  
Intent to Treat Population     115     115     67  
Modified Intent to Treat Population     112     115     67  
COMPLETED     103     106     63  
NOT COMPLETED     15     11     6  
Adverse Event                 1                 3                 1  
Protocol Violation                 3                 1                 1  
Lack of Efficacy                 0                 0                 0  
Lost to Follow-up                 6                 5                 1  
Withdrawal by Subject                 2                 0                 1  
Other Event                 3                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
3900 mg/Day Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1950 mg/Day One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
Placebo Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
Total Total of all reporting groups

Baseline Measures
    3900 mg/Day     1950 mg/Day     Placebo     Total  
Number of Participants  
[units: participants]
 		  115     115     67     297  
Age [1]
[units: years]
Mean ± Standard Deviation 		  39  ± 6     40  ± 6     39  ± 6     39  ± 6  
Gender  
[units: participants]
 		       
Female     115     115     67     297  
Male     0     0     0     0  
[1] Intent to Treat Population



  Outcome Measures
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1.  Primary:   Mean Reduction From Baseline in Menstrual Blood Loss (MBL)   [ Time Frame: Baseline MBL over 3 menstrual cycles ]
  Show Outcome Measure 1

2.  Secondary:   Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding   [ Time Frame: Baseline scores over 3 menstrual cycles ]
  Show Outcome Measure 2

3.  Secondary:   Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding   [ Time Frame: Baseline scores over 3 menstrual cycles ]
  Show Outcome Measure 3

4.  Secondary:   Responder Analysis - Reduction in Large Stains   [ Time Frame: Baseline over 3 mentrual cycles ]
  Show Outcome Measure 4


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


No publications provided by Ferring Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00401193     History of Changes
Other Study ID Numbers: XP12B-MR-301
Study First Received: November 9, 2006
Results First Received: August 31, 2009
Last Updated: June 9, 2010
Health Authority: United States: Food and Drug Administration