Efficacy and Safety Study of XP12B in Women With Menorrhagia

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386308
• Other study ID #: XP12B-MR-303
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2006
• Last updated: May 3, 2011
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2010
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Menorrhagia

Intervention

Drug:
• Tranexamic acid tablets
3900 mg/Day
• Placebo tablets

Locations

Country	Name	City	State
United States	Investigative Site	Abington	Pennsylvania
United States	Investigative Site	Amite	Louisiana
United States	Investigative Site	Atlanta	Georgia
United States	Investigative Site	Atlanta	Georgia
United States	Investigative Site	Baton Rouge	Louisiana
United States	Investigative Site	Canfield	Ohio
United States	Investigative Site	Carmichael	California
United States	Investigative Site	Centerville	Ohio
United States	Investigative Site	Charleston	South Carolina
United States	Investigative Site	Charleston	West Virginia
United States	Investigative Site	Chattanooga	Tennessee
United States	Investigative Site	Cleveland	Ohio
United States	Investigative Site	Columbia	South Carolina
United States	Investigative Site	Dallas	Texas
United States	Investigative Site	Decatur	Georgia
United States	Investigative Site	Denver	Colorado
United States	Investigative Site	Eugene	Oregon
United States	Investigative Site	Greenville	South Carolina
United States	Investigative Site	Greer	South Carolina
United States	Investigative Site	Groton	Connecticut
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Huntington	West Virginia
United States	Investigative Site	Idaho Falls	Idaho
United States	Investigative Site	Inverness	Florida
United States	Investigative Site	Jenkintown	Pennsylvania
United States	Investigative Site	Knoxville	Tennessee
United States	Investigative Site	Lakewood	Colorado
United States	Investigative Site	Lawrenceville	New Jersey
United States	Investigative Site	Little Rock	Arkansas
United States	Investigative Site	Marrero	Louisiana
United States	Investigative Site	Medford	Oregon
United States	Investigative Site	Memphis	Tennessee
United States	Investigative Site	Menomonee Falls	Wisconsin
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Norman	Oklahoma
United States	Investigative Site	Oklahoma City	Oklahoma
United States	Investigative Site	Paw Paw	Michigan
United States	Investigative Site	Portland	Oregon
United States	Investigative Site	Reading	Pennsylvania
United States	Investigative Site	Salem	Oregon
United States	Investigative Site	San Diego	California
United States	Investigative Site	Sandy	Utah
United States	Investigative Site	Savannah	Georgia
United States	Investigative Site	Scottsbluff	Nebraska
United States	Investigative Site	Shreveport	Louisiana
United States	Investigative Site	Spokane	Washington
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Upland	California
United States	Investigative Site	West Hartford	Connecticut
United States	Investigative Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Reduction From Baseline in Menstrual Blood Loss (MBL)	reduction of menstrual blood loss in mL	Baseline MBL over 6 menstrual cycles	No
Secondary	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	Change from Baseline scores over 6 menstrual cycles	No
Secondary	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	Change from Baseline scores over 6 menstrual cycles	No
Secondary	Responder Analysis - Reduction in Large Stains	Percentage of subjects who experienced a reduction from baseline in the frequency of large stains	Reduction from Baseline over 6 menstrual cycles	No