Safety Study of XP12B in Women With Menorrhagia

June 9, 2010 updated by: Ferring Pharmaceuticals

Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

784

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, 35235
        • Investigative Site
      • Mobile, Alabama, United States, 36608
        • Investigative Site
      • Montgomery, Alabama, United States, 36106
        • Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigative Site
      • Phoenix, Arizona, United States, 85035
        • Investigative Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Investigative Site
      • Little Rock, Arkansas, United States, 72205
        • Investigative Site
    • California
      • San Diego, California, United States, 92103
        • Investigative Site
      • San Diego, California, United States, 92108
        • Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Investigative Site
      • Denver, Colorado, United States, 80202
        • Investigative Site
    • Florida
      • Ft. Myers, Florida, United States, 33916
        • Investigative Site
      • Miami, Florida, United States, 33186
        • Investigative Site
      • New Port Richey, Florida, United States, 34652
        • Investigative Site
      • Ocala, Florida, United States, 34471
        • Investigative Site
      • Pinellas Park, Florida, United States, 33781
        • Investigative Site
      • Venice, Florida, United States, 34292
        • Investigative Site
      • West Palm Beach, Florida, United States, 33407
        • Investigative Site
      • West Palm Beach, Florida, United States, 33409
        • Investigative Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Investigative Site
      • Roswell, Georgia, United States, 30075
        • Investigative Site
      • Savannah, Georgia, United States, 31406
        • Investigative Site
      • Savannah, Georgia, United States, 31405
        • Investigative Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Investigative Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Investigative Site
      • Indianapolis, Indiana, United States, 46250
        • Investigative Site
      • South Bend, Indiana, United States, 46601
        • Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Investigative Site
      • Louisville, Kentucky, United States, 40291
        • Investigative Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Investigative Site
    • Michigan
      • Portage, Michigan, United States, 49024
        • Investigative Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Investigative Site
      • St. Louis, Missouri, United States, 63117
        • Investigative Site
      • St. Louis, Missouri, United States, 63141
        • Investigative Site
    • Montana
      • Billings, Montana, United States, 59102
        • Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Investigative Site
      • Las Vegas, Nevada, United States, 89030
        • Investigative Site
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Investigative Site
    • New York
      • Johnson City, New York, United States, 13790
        • Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Investigative Site
      • Durham, North Carolina, United States, 27710
        • Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Investigative Site
      • Cincinnati, Ohio, United States, 45249
        • Investigative Site
      • Toledo, Ohio, United States, 43614
        • Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigative Site
      • Wexford, Pennsylvania, United States, 15090
        • Investigative Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Investigative Site
      • Nashville, Tennessee, United States, 37208
        • Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Investigative Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Investigative Site
      • Tacoma, Washington, United States, 98405
        • 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 occuring menstrual periods

Exclusion Criteria:

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

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: XP12B (tranexamic acid tablets)
Drug: Tranexamic acid tablets (XP12B)
Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
Other Names:
  • Lysteda
  • XP12B
  • tranexamic acid tablets
  • XP12B-MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With at Least One Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.
Up to 27 menstrual cycles
Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.
Up to 27 menstrual cycles
Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.
Up to 27 menstrual cycles
Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.
Up to 27 menstrual cycles
Number of Subjects With at Least One Serious Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.
Up to 27 menstrual cycles
Number of Subjects With at Least One Life-Threatening Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.
Up to 27 menstrual cycles
Number of Subjects With Adverse Events That Led to Discontinuation From the Study
Time Frame: Up to 27 menstrual cycles
The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator
Up to 27 menstrual cycles
Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study
Time Frame: Up to 27 menstrual cycles
Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.
Up to 27 menstrual cycles
Number of Subjects Who Died During the Study
Time Frame: Up to 27 menstrual cycles
Number of subjects who died, for any reason, during the study
Up to 27 menstrual 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

June 1, 2005

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

June 8, 2005

First Submitted That Met QC Criteria

June 8, 2005

First Posted (ESTIMATE)

June 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2010

Last Update Submitted That Met QC Criteria

June 9, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XP12B-MR-302

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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