Clinical trial NCT00401193: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menorrhagia
Heavy Menstrual Bleeding
Keywords: Menorrhagia
Heavy Menstrual Bleeding
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
timeFrame: Baseline MBL over 3 menstrual cycles
Secondary outcomes:
measure: Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
timeFrame: Baseline scores over 3 menstrual cycles
measure: Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
timeFrame: Baseline scores over 3 menstrual cycles
measure: Responder Analysis - Reduction in Large Stains
timeFrame: Baseline over 3 mentrual cycles
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: Searcy
country: United States
facility: Investigative Site
state: Arkansas
city: Los Alamitos
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Groton
country: United States
facility: Investigative Site
state: Connecticut
city: Gainesville
country: United States
facility: Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Investigative Site
state: Florida
city: Lighthouse Point
country: United States
facility: Investigative Site
state: Florida
city: Miami Beach
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: New Port Richey
country: United States
facility: Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Investigative Site
state: Georgia
city: Decatur
country: United States
facility: Investigative Site
state: Georgia
city: Boise
country: United States
facility: Investigative Site
state: Idaho
city: Idaho Falls
country: United States
facility: Investigative Site
state: Idaho
city: Bloomington
country: United States
facility: Investigative Site
state: Indiana
city: Newton
country: United States
facility: Investigative Site
state: Kansas
city: Overland Park
country: United States
facility: Investigative Site
state: Kansas
city: Marrero
country: United States
facility: Investigative Site
state: Louisiana
city: Baltimore
country: United States
facility: Investigative Site
state: Maryland
city: Ann Arbor
country: United States
facility: Investigative Site
state: Michigan
city: Bingham Farms
country: United States
facility: Investigative Site
state: Michigan
city: Grand Rapids
country: United States
facility: Investigative Site
state: Michigan
city: Paw Paw
country: United States
facility: Investigative Site
state: Michigan
city: St. Clair Shores
country: United States
facility: Investigative Site
state: Michigan
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: Missoula
country: United States
facility: Investigative Site
state: Montana
city: McCook
country: United States
facility: Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Lawrenceville
country: United States
facility: Investigative Site
state: New Jersey
city: Moorestown
country: United States
facility: Investigative Site
state: New Jersey
city: New Brunswick
country: United States
facility: Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigative Site
state: New Mexico
city: New York
country: United States
facility: Investigative Site
state: New York
city: Rochester
country: United States
facility: Investigative Site
state: New York
city: Durham
country: United States
facility: Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigative Site
state: North Carolina
city: Bismarck
country: United States
facility: Investigative Site
state: North Dakota
city: Cleveland
country: United States
facility: Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Investigative Site
state: Ohio
city: Gallipolis
country: United States
facility: Investigative Site
state: Ohio
city: Zanesville
country: United States
facility: Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Investigative Site
state: Oregon
city: Portland
country: United States
facility: Investigative Site
state: Oregon
city: Levittown
country: United States
facility: Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigative Site
state: Pennsylvania
city: Phoenixville
country: United States
facility: Investigative Site
state: Pennsylvania
city: Strafford
country: United States
facility: Investigative Site
state: Pennsylvania
city: Wexford
country: United States
facility: Investigative Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: Investigative Site
state: Pennsylvania
city: Greenville
country: United States
facility: Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Investigative Site
state: South Dakota
city: Bristol
country: United States
facility: Investigative Site
state: Tennessee
city: Clarksville
country: United States
facility: Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Bryan
country: United States
facility: Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Plano
country: United States
facility: Investigative Site
state: Texas
city: Temple
country: United States
facility: Investigative Site
state: Texas
city: Waco
country: United States
facility: Investigative Site
state: Texas
city: Webster
country: United States
facility: Investigative Site
state: Texas
city: Woodlands
country: United States
facility: Investigative Site
state: Texas
city: Pleasant Grove
country: United States
facility: Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
city: West Jordan
country: United States
facility: Investigative Site
state: Utah
city: West Valley City
country: United States
facility: Investigative Site
state: Utah
city: Burlington
country: United States
facility: Investigative Site
state: Vermont
city: Norfolk
country: United States
facility: Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Investigative Site
state: Virginia
city: Renton
country: United States
facility: Investigative Site
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
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.
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.