Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
784 participants
INTERVENTIONAL
2005-06-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XP12B (tranexamic acid tablets)
Tranexamic acid tablets (XP12B)
Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
Interventions
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Tranexamic acid tablets (XP12B)
Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-49 years of age
* Regularly occuring menstrual periods
Exclusion Criteria
* History of bilateral oophorectomy or hysterectomy
18 Years
49 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Ferring Pharmaceuticals
Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
Mobile, Alabama, United States
Investigative Site
Montgomery, Alabama, United States
Investigative Site
Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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San Diego, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Pinellas Park, Florida, United States
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Venice, Florida, United States
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West Palm Beach, Florida, United States
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West Palm Beach, Florida, United States
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Alpharetta, Georgia, United States
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Roswell, Georgia, United States
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Savannah, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Champaign, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Shreveport, Louisiana, United States
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Portage, Michigan, United States
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Chaska, Minnesota, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Moorestown, New Jersey, United States
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Albuquerque, New Mexico, United States
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Johnson City, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Wexford, Pennsylvania, United States
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Columbia, South Carolina, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Norfolk, Virginia, United States
Investigative Site
Seattle, Washington, United States
Investigative Site
Tacoma, Washington, United States
Countries
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References
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Muse K, Lukes AS, Gersten J, Waldbaum A, Mabey RG, Trott E. Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid. Womens Health (Lond). 2011 Nov;7(6):699-707. doi: 10.2217/whe.11.65. Epub 2011 Aug 25.
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.
Other Identifiers
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XP12B-MR-302
Identifier Type: -
Identifier Source: org_study_id
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