Clinical trial NCT00386308: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menorrhagia
Heavy Menstrual Bleeding
Keywords: Heavy Menstrual Bleeding
Menorrhagia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 196
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

Primary outcomes:
measure: Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
timeFrame: Baseline MBL over 6 menstrual cycles
Secondary outcomes:
measure: Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
timeFrame: Change from Baseline scores over 6 menstrual cycles
measure: Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
timeFrame: Change from Baseline scores over 6 menstrual cycles
measure: Responder Analysis - Reduction in Large Stains
timeFrame: Reduction from Baseline over 6 menstrual cycles
Other outcomes:
Locations:
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: Carmichael
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Upland
country: United States
facility: Investigative Site
state: California
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Lakewood
country: United States
facility: Investigative Site
state: Colorado
city: Groton
country: United States
facility: Investigative Site
state: Connecticut
city: West Hartford
country: United States
facility: Investigative Site
state: Connecticut
city: Inverness
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Investigative Site
state: Georgia
city: Decatur
country: United States
facility: Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Investigative Site
state: Georgia
city: Idaho Falls
country: United States
facility: Investigative Site
state: Idaho
city: Amite
country: United States
facility: Investigative Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Investigative Site
state: Louisiana
city: Marrero
country: United States
facility: Investigative Site
state: Louisiana
city: Shreveport
country: United States
facility: Investigative Site
state: Louisiana
city: Paw Paw
country: United States
facility: Investigative Site
state: Michigan
city: Scottsbluff
country: United States
facility: Investigative Site
state: Nebraska
city: Lawrenceville
country: United States
facility: Investigative Site
state: New Jersey
city: Canfield
country: United States
facility: Investigative Site
state: Ohio
city: Centerville
country: United States
facility: Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Investigative Site
state: Ohio
city: Zanesville
country: United States
facility: Investigative Site
state: Ohio
city: Norman
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: Medford
country: United States
facility: Investigative Site
state: Oregon
city: Portland
country: United States
facility: Investigative Site
state: Oregon
city: Salem
country: United States
facility: Investigative Site
state: Oregon
city: Abington
country: United States
facility: Investigative Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Investigative Site
state: Pennsylvania
city: Reading
country: United States
facility: Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Investigative Site
state: South Carolina
city: Chattanooga
country: United States
facility: Investigative Site
state: Tennessee
city: Knoxville
country: United States
facility: Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Sandy
country: United States
facility: Investigative Site
state: Utah
city: Spokane
country: United States
facility: Investigative Site
state: Washington
city: Charleston
country: United States
facility: Investigative Site
state: West Virginia
city: Huntington
country: United States
facility: Investigative Site
state: West Virginia
city: Menomonee Falls
country: United States
facility: Investigative Site
state: Wisconsin
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
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.
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.