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Efficacy and Safety of XP12B in Women With Menorrhagia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401193
First Posted: November 20, 2006
Last Update Posted: May 13, 2015
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.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose
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 Intervention Phase
Menorrhagia Heavy Menstrual Bleeding Drug: Tranexamic acid tablets Drug: Placebo tablets Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Mean Reduction From Baseline in Menstrual Blood Loss (MBL) [ Time Frame: Baseline MBL over 3 menstrual cycles ]
    reduction of menstrual blood loss in mL


Secondary Outcome Measures:
  • Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Baseline scores over 3 menstrual cycles ]
    A positive unit change of the 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

  • Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Baseline scores over 3 menstrual cycles ]
    A positive unit change of the 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

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


Enrollment: 304
Study Start Date: November 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Tranexamic acid tablets
3900 mg/Day
Other Names:
  • Lysteda
  • XP12B
Experimental: 2 Drug: Tranexamic acid tablets
1950 mg/Day
Other Names:
  • Lysteda
  • XP12B
Placebo Comparator: 3 Drug: Placebo tablets

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 for birth control
  Contacts and Locations
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): NCT00401193


  Show 83 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00401193     History of Changes
Other Study ID Numbers: XP12B-MR-301
First Submitted: November 9, 2006
First Posted: November 20, 2006
Results First Submitted: August 31, 2009
Results First Posted: February 24, 2010
Last Update Posted: May 13, 2015
Last Verified: April 2015

Keywords provided by Ferring Pharmaceuticals:
Menorrhagia
Heavy Menstrual Bleeding

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