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Efficacy and Safety of XP12B in Women With Menorrhagia

NCT ID: NCT00401193

Last Updated: 2015-05-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Menorrhagia Heavy Menstrual Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Tranexamic acid tablets

Intervention Type DRUG

3900 mg/Day

2

Group Type EXPERIMENTAL

Tranexamic acid tablets

Intervention Type DRUG

1950 mg/Day

3

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

Interventions

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Tranexamic acid tablets

3900 mg/Day

Intervention Type DRUG

Tranexamic acid tablets

1950 mg/Day

Intervention Type DRUG

Placebo tablets

Intervention Type DRUG

Other Intervention Names

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Lysteda XP12B Lysteda XP12B

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Groton, Connecticut, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Lighthouse PT, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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New Port Richey, Florida, United States

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Sarasota, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Bloomington, Indiana, United States

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Newton, Kansas, United States

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Overland Park, Kansas, United States

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Marrero, Louisiana, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Bingham Farms, Michigan, United States

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Grand Rapids, Michigan, United States

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Paw Paw, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Kansas City, Missouri, United States

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Missoula, Montana, United States

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McCook, Nebraska, United States

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Las Vegas, Nevada, United States

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Lawrenceville, New Jersey, United States

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Moorestown, New Jersey, United States

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New Brunswick, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Gallipolis, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Levittown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Strafford, Pennsylvania, United States

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Wexford, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Greenville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Bristol, Tennessee, United States

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Clarksville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Bryan, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Temple, Texas, United States

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The Woodlands, Texas, United States

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Waco, Texas, United States

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Webster, Texas, United States

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Pleasant Grove, Utah, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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West Valley City, Utah, United States

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Burlington, Vermont, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21777897 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20942615 (View on PubMed)

Other Identifiers

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XP12B-MR-301

Identifier Type: -

Identifier Source: org_study_id

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