Efficacy and Safety of XP12B in Women With Menorrhagia

April 23, 2015 updated by: Ferring Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Investigative Site
      • Tucson, Arizona, United States, 85712
        • Investigative Site
      • Tucson, Arizona, United States, 85710
        • Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigative Site
      • Searcy, Arkansas, United States, 72143
        • Investigative Site
    • California
      • Los Alamitos, California, United States, 90720
        • Investigative Site
      • Los Angeles, California, United States, 90027
        • Investigative Site
      • San Diego, California, United States, 92108
        • Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80202
        • Investigative Site
    • Connecticut
      • Groton, Connecticut, United States, 06340
        • Investigative Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Investigative Site
      • Lighthouse Point, Florida, United States, 33064
        • Investigative Site
      • Miami, Florida, United States, 33186
        • Investigative Site
      • Miami Beach, Florida, United States, 33141
        • Investigative Site
      • New Port Richey, Florida, United States, 34652
        • Investigative Site
      • Sarasota, Florida, United States, 34233
        • Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Investigative Site
      • Decatur, Georgia, United States, 30033
        • Investigative Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Investigative Site
      • Idaho Falls, Idaho, United States, 83404
        • Investigative Site
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Investigative Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Investigative Site
      • Overland Park, Kansas, United States, 66215
        • Investigative Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21230
        • Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Investigative Site
      • Bingham Farms, Michigan, United States, 48025
        • Investigative Site
      • Grand Rapids, Michigan, United States, 49506
        • Investigative Site
      • Paw Paw, Michigan, United States, 49079
        • Investigative Site
      • St. Clair Shores, Michigan, United States, 48081
        • Investigative Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Investigative Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Investigative Site
    • Nebraska
      • McCook, Nebraska, United States, 69001
        • Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Investigative Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Investigative Site
      • Moorestown, New Jersey, United States, 08057
        • Investigative Site
      • New Brunswick, New Jersey, United States, 08903
        • Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Investigative Site
    • New York
      • New York, New York, United States, 10017
        • Investigative Site
      • Rochester, New York, United States, 14621
        • Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Investigative Site
      • Raleigh, North Carolina, United States, 27607
        • Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Investigative Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Investigative Site
      • Cleveland, Ohio, United States, 44121
        • Investigative Site
      • Gallipolis, Ohio, United States, 45631
        • Investigative Site
      • Zanesville, Ohio, United States, 43701
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Investigative Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Investigative Site
      • Portland, Oregon, United States, 97205
        • Investigative Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Investigative Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigative Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Investigative Site
      • Phoenixville, Pennsylvania, United States, 19460
        • Investigative Site
      • Strafford, Pennsylvania, United States, 19087
        • Investigative Site
      • Wexford, Pennsylvania, United States, 15090
        • Investigative Site
      • Wynnewood, Pennsylvania, United States, 19096
        • Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Investigative Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Investigative Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Investigative Site
      • Clarksville, Tennessee, United States, 37043
        • Investigative Site
      • Nashville, Tennessee, United States, 37203
        • Investigative Site
    • Texas
      • Austin, Texas, United States, 78737
        • Investigative Site
      • Bryan, Texas, United States, 77802
        • Investigative Site
      • Fort Worth, Texas, United States, 76132
        • Investigative Site
      • Houston, Texas, United States, 77030
        • Investigative Site
      • Plano, Texas, United States, 75093
        • Investigative Site
      • Temple, Texas, United States, 46502
        • Investigative Site
      • Waco, Texas, United States, 76712
        • Investigative Site
      • Webster, Texas, United States, 77598
        • Investigative Site
      • Woodlands, Texas, United States, 77380
        • Investigative Site
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Investigative Site
      • Salt Lake City, Utah, United States, 84124
        • Investigative Site
      • West Jordan, Utah, United States, 84088
        • Investigative Site
      • West Valley City, Utah, United States, 84120
        • Investigative Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Investigative Site
      • Richmond, Virginia, United States, 23225
        • Investigative Site
    • Washington
      • Renton, Washington, United States, 98055
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Tranexamic acid tablets
3900 mg/Day
Other Names:
  • Lysteda
  • XP12B
Drug: Tranexamic acid tablets
1950 mg/Day
Other Names:
  • Lysteda
  • XP12B
Experimental: 2
Drug: Tranexamic acid tablets
3900 mg/Day
Other Names:
  • Lysteda
  • XP12B
Drug: Tranexamic acid tablets
1950 mg/Day
Other Names:
  • Lysteda
  • XP12B
Placebo Comparator: 3
Drug: Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
Time Frame: Baseline MBL over 3 menstrual cycles
reduction of menstrual blood loss in mL
Baseline MBL over 3 menstrual cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline scores over 3 menstrual cycles
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
Baseline scores over 3 menstrual cycles
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
Baseline over 3 mentrual cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XP12B-MR-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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