Efficacy and Safety of XP12B in Women With Menorrhagia

NCT00401193 | Completed Phase 3 Results DMC

• 1 other identifier: XP12B-MR-301
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 83

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.

Conditions

Menorrhagia; Heavy Menstrual Bleeding

Keywords

Menorrhagia; Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• Mean Reduction From Baseline in Menstrual Blood Loss (MBL)

  reduction of menstrual blood loss in mL

  Baseline MBL over 3 menstrual cycles

Secondary Outcomes (3)

• Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding

  Baseline scores over 3 menstrual cycles

• Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding

  Baseline scores over 3 menstrual cycles

• Responder Analysis - Reduction in Large Stains

  Baseline over 3 mentrual cycles

Study Arms (3)

1

EXPERIMENTAL

Drug: Tranexamic acid tablets

2

EXPERIMENTAL

Drug: Tranexamic acid tablets

3

PLACEBO COMPARATOR

Drug: Placebo tablets

Interventions

Tranexamic acid tablets DRUG

3900 mg/Day

Also known as: Lysteda, XP12B

1

Placebo tablets DRUG

3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 for birth control

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (83)

Investigative Site

Birmingham, Alabama, 35209, United States

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Phoenix, Arizona, 85015, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72205, United States

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Searcy, Arkansas, 72143, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90027, United States

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San Diego, California, 92108, United States

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Denver, Colorado, 80202, United States

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Groton, Connecticut, 06340, United States

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Gainesville, Florida, 32610, United States

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Jacksonville, Florida, 32216, United States

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Lighthouse PT, Florida, 33064, United States

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Miami, Florida, 33186, United States

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Miami Beach, Florida, 33141, United States

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New Port Richey, Florida, 34652, United States

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Sarasota, Florida, 34233, United States

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Atlanta, Georgia, 30328, United States

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Decatur, Georgia, 30033, United States

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Boise, Idaho, 83712, United States

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Idaho Falls, Idaho, 83404, United States

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Bloomington, Indiana, 47403, United States

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Newton, Kansas, 67114, United States

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Overland Park, Kansas, 66215, United States

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Marrero, Louisiana, 70072, United States

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Baltimore, Maryland, 21230, United States

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Ann Arbor, Michigan, 48106, United States

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Bingham Farms, Michigan, 48025, United States

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Grand Rapids, Michigan, 49506, United States

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Paw Paw, Michigan, 49079, United States

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Saint Clair Shores, Michigan, 48081, United States

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Kansas City, Missouri, 64114, United States

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Missoula, Montana, 59808, United States

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McCook, Nebraska, 69001, United States

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Las Vegas, Nevada, 89128, United States

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Lawrenceville, New Jersey, 08648, United States

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Moorestown, New Jersey, 08057, United States

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New Brunswick, New Jersey, 08903, United States

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Albuquerque, New Mexico, 87131, United States

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New York, New York, 10017, United States

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Rochester, New York, 14621, United States

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Durham, North Carolina, 27713, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Cleveland, Ohio, 44121, United States

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Cleveland, Ohio, 44122, United States

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Gallipolis, Ohio, 45631, United States

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Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73112, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97205, United States

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Levittown, Pennsylvania, 19056, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19114, United States

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Phoenixville, Pennsylvania, 19460, United States

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Strafford, Pennsylvania, 19087, United States

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Wexford, Pennsylvania, 15090, United States

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Wynnewood, Pennsylvania, 19096, United States

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Greenville, South Carolina, 29605, United States

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Sioux Falls, South Dakota, 57104, United States

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Bristol, Tennessee, 37620, United States

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Clarksville, Tennessee, 37043, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78737, United States

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Bryan, Texas, 77802, United States

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Fort Worth, Texas, 76132, United States

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Houston, Texas, 77030, United States

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Plano, Texas, 75093, United States

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Temple, Texas, 46502, United States

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The Woodlands, Texas, 77380, United States

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Waco, Texas, 76712, United States

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Webster, Texas, 77598, United States

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Pleasant Grove, Utah, 84062, United States

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Salt Lake City, Utah, 84124, United States

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West Jordan, Utah, 84088, United States

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West Valley City, Utah, 84120, United States

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Burlington, Vermont, 05401, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23225, United States

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Renton, Washington, 98055, United States

Location

Related Publications (2)

• 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.

  PMID: 21777897 DERIVED

• 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.

  PMID: 20942615 DERIVED

MeSH Terms

Conditions

Menorrhagia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 13, 2015
• Results First Posted: February 24, 2010

Record last verified: 2015-04

Locations

US (83)