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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401193

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

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013