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Efficacy and Safety Study of XP12B in Women With Menorrhagia

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ClinicalTrials.gov Identifier: NCT00386308
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : February 22, 2010
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Brief Summary:
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Condition or disease Intervention/treatment Phase
Menorrhagia Heavy Menstrual Bleeding Drug: Tranexamic acid tablets Drug: Placebo tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Study Start Date : October 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Tranexamic acid tablets
3900 mg/Day
Other Names:
  • Lysteda
  • XP12B
Placebo Comparator: 2 Drug: Placebo tablets
Other Names:
  • Lysteda
  • XP12B



Primary Outcome Measures :
  1. Mean Reduction From Baseline in Menstrual Blood Loss (MBL) [ Time Frame: Baseline MBL over 6 menstrual cycles ]
    reduction of menstrual blood loss in mL


Secondary Outcome Measures :
  1. Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Change from Baseline scores over 6 menstrual cycles ]
    A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited

  2. Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Change from Baseline scores over 6 menstrual cycles ]
    A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited

  3. Responder Analysis - Reduction in Large Stains [ Time Frame: Reduction from Baseline over 6 menstrual cycles ]
    Percentage of subjects who experienced a reduction from baseline in the frequency of large stains



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with menorrhagia
  • 18-49 years of age
  • Regularly occurring menstrual periods

Exclusion Criteria:

  • History or presence of clinically significant disease or abnormalities that may confound the study
  • History of bilateral oophorectomy or hysterectomy
  • Hormone therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386308


  Show 52 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00386308     History of Changes
Other Study ID Numbers: XP12B-MR-303
First Posted: October 11, 2006    Key Record Dates
Results First Posted: February 22, 2010
Last Update Posted: May 4, 2011
Last Verified: June 2010

Keywords provided by Ferring Pharmaceuticals:
Heavy Menstrual Bleeding
Menorrhagia

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