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Efficacy and Safety Study 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
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 Heavy Menstrual Bleeding, Menorrhagia

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

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 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
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
Percentage of subjects who experienced a reduction from baseline in the frequency of large stains

Full Information

First Posted
October 6, 2006
Last Updated
May 3, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00386308
Brief Title
Efficacy and Safety Study 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
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

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
Heavy Menstrual Bleeding, Menorrhagia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
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)
Placebo tablets
Other Intervention Name(s)
Lysteda, XP12B
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 6 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 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
Change from Baseline scores over 6 menstrual cycles
Title
Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
Description
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
Time Frame
Change from Baseline scores over 6 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
Reduction from Baseline over 6 menstrual 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
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigative Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Investigative Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Investigative Site
City
Groton
State/Province
Connecticut
ZIP/Postal Code
06340
Country
United States
Facility Name
Investigative Site
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Facility Name
Investigative Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Investigative Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Investigative Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
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
Amite
State/Province
Louisiana
ZIP/Postal Code
70422
Country
United States
Facility Name
Investigative Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Investigative Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Investigative Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
Investigative Site
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Facility Name
Investigative Site
City
Scottsbluff
State/Province
Nebraska
ZIP/Postal Code
69361
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
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Investigative Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Investigative Site
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Investigative Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
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
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Investigative Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Investigative Site
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Investigative Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Investigative Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Investigative Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigative Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigative Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Investigative Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
Investigative Site
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Investigative Site
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21043553
Citation
Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.
Results Reference
derived
PubMed Identifier
20859150
Citation
Lukes AS, Moore KA, Muse KN, Gersten JK, Hecht BR, Edlund M, Richter HE, Eder SE, Attia GR, Patrick DL, Rubin A, Shangold GA. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):865-875. doi: 10.1097/AOG.0b013e3181f20177.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study of XP12B in Women With Menorrhagia

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