Efficacy and Safety Study of XP12B in Women With Menorrhagia

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00386308
First received: October 6, 2006
Last updated: May 3, 2011
Last verified: June 2010
  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:


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 6 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: Change from Baseline scores over 6 menstrual cycles ] [ Designated as safety issue: No ]
    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

  • Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding [ Time Frame: Change from Baseline scores over 6 menstrual cycles ] [ Designated as safety issue: No ]
    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

  • Responder Analysis - Reduction in Large Stains [ Time Frame: Reduction from Baseline over 6 menstrual cycles ] [ Designated as safety issue: No ]
    Percentage of subjects who experienced a reduction from baseline in the frequency of large stains


Enrollment: 196
Study Start Date: October 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
Placebo Comparator: 2 Drug: Placebo tablets
Other Names:
  • Lysteda
  • XP12B

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386308

  Show 52 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: NCT00386308     History of Changes
Other Study ID Numbers: XP12B-MR-303
Study First Received: October 6, 2006
Results First Received: December 11, 2009
Last Updated: May 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Heavy Menstrual Bleeding
Menorrhagia

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

ClinicalTrials.gov processed this record on October 29, 2014