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Efficacy and Safety of XP12B in Women With Menorrhagia

Primary Purpose

Menorrhagia, Heavy Menstrual Bleeding

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid tablets
Tranexamic acid tablets
Placebo tablets
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Menorrhagia, Heavy Menstrual Bleeding

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
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
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
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
Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

Full Information

First Posted
November 9, 2006
Last Updated
April 23, 2015
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00401193
Brief Title
Efficacy and Safety of XP12B in Women With Menorrhagia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia, Heavy Menstrual Bleeding
Keywords
Menorrhagia, Heavy Menstrual Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid tablets
Other Intervention Name(s)
Lysteda, XP12B
Intervention Description
3900 mg/Day
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid tablets
Other Intervention Name(s)
Lysteda, XP12B
Intervention Description
1950 mg/Day
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Primary Outcome Measure Information:
Title
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
Description
reduction of menstrual blood loss in mL
Time Frame
Baseline MBL over 3 menstrual cycles
Secondary Outcome Measure Information:
Title
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
Description
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
Time Frame
Baseline scores over 3 menstrual cycles
Title
Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
Description
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
Time Frame
Baseline scores over 3 menstrual cycles
Title
Responder Analysis - Reduction in Large Stains
Description
Percentage of subjects who experienced a reduction from baseline in the frequency of large stains
Time Frame
Baseline over 3 mentrual cycles

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
21777897
Citation
Freeman EW, Lukes A, VanDrie D, Mabey RG, Gersten J, Adomako TL. A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding. Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14.
Results Reference
derived
PubMed Identifier
20942615
Citation
Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of XP12B in Women With Menorrhagia

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