Efficacy and Safety Study of XP12B in Women With Menorrhagia
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
1 other identifier
interventional
196
1 country
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2006
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
February 22, 2010
CompletedMay 4, 2011
June 1, 2010
1.6 years
October 6, 2006
December 11, 2009
May 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
reduction of menstrual blood loss in mL
Baseline MBL over 6 menstrual cycles
Secondary Outcomes (3)
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
Change from Baseline scores over 6 menstrual cycles
Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
Change from Baseline scores over 6 menstrual cycles
Responder Analysis - Reduction in Large Stains
Reduction from Baseline over 6 menstrual cycles
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Women with menorrhagia
- years of age
- Regularly occurring menstrual periods
You may not qualify if:
- History or presence of clinically significant disease or abnormalities that may confound the study
- History of bilateral oophorectomy or hysterectomy
- Hormone therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Investigative Site
Tucson, Arizona, 85712, United States
Investigative Site
Tucson, Arizona, 85741, United States
Investigative Site
Little Rock, Arkansas, 72205, United States
Investigative Site
Carmichael, California, 95608, United States
Investigative Site
San Diego, California, 92123, United States
Investigative Site
Upland, California, 91786, United States
Investigative Site
Denver, Colorado, 80206, United States
Investigative Site
Lakewood, Colorado, 80228, United States
Investigative Site
Groton, Connecticut, 06340, United States
Investigative Site
West Hartford, Connecticut, 06117, United States
Investigative Site
Inverness, Florida, 34452, United States
Investigative Site
Miami, Florida, 33133, United States
Investigative Site
Miami, Florida, 33136, United States
Investigative Site
Atlanta, Georgia, 30328, United States
Investigative Site
Atlanta, Georgia, 30342, United States
Investigative Site
Decatur, Georgia, 30033, United States
Investigative Site
Savannah, Georgia, 31406, United States
Investigative Site
Idaho Falls, Idaho, 83404, United States
Investigative Site
Amite, Louisiana, 70422, United States
Investigative Site
Baton Rouge, Louisiana, 70808, United States
Investigative Site
Marrero, Louisiana, 70072, United States
Investigative Site
Shreveport, Louisiana, 71115, United States
Investigative Site
Paw Paw, Michigan, 49079, United States
Investigative Site
Scottsbluff, Nebraska, 69361, United States
Investigative Site
Lawrenceville, New Jersey, 08648, United States
Investigative Site
Canfield, Ohio, 44406, United States
Investigative Site
Centerville, Ohio, 45459, United States
Investigative Site
Cleveland, Ohio, 44122, United States
Investigative Site
Zanesville, Ohio, 43701, United States
Investigative Site
Norman, Oklahoma, 73071, United States
Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Investigative Site
Eugene, Oregon, 97401, United States
Investigative Site
Medford, Oregon, 97504, United States
Investigative Site
Portland, Oregon, 97210, United States
Investigative Site
Salem, Oregon, 97301, United States
Investigative Site
Abington, Pennsylvania, 19001, United States
Investigative Site
Jenkintown, Pennsylvania, 19046, United States
Investigative Site
Reading, Pennsylvania, 19606, United States
Investigative Site
Charleston, South Carolina, 29401, United States
Investigative Site
Columbia, South Carolina, 29201, United States
Investigative Site
Greenville, South Carolina, 29615, United States
Investigative Site
Greer, South Carolina, 29651, United States
Investigative Site
Chattanooga, Tennessee, 37403, United States
Investigative Site
Knoxville, Tennessee, 37920, United States
Investigative Site
Memphis, Tennessee, 38119, United States
Investigative Site
Dallas, Texas, 75235, United States
Investigative Site
Houston, Texas, 77030, United States
Investigative Site
Sandy City, Utah, 84070, United States
Investigative Site
Spokane, Washington, 99207, United States
Investigative Site
Charleston, West Virginia, 25301, United States
Investigative Site
Huntington, West Virginia, 25701, United States
Investigative Site
Menomonee Falls, Wisconsin, 53051, United States
Related Publications (2)
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.
PMID: 21043553DERIVEDLukes 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.
PMID: 20859150DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 11, 2006
Study Start
October 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 4, 2011
Results First Posted
February 22, 2010
Record last verified: 2010-06