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Efficacy and Safety Study of XP12B in Women With Menorrhagia

NCT ID: NCT00386308

Last Updated: 2011-05-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

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 PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

Interventions

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Tranexamic acid tablets

3900 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
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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Ferring Pharmaceuticals

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Investigative Site

Tucson, Arizona, United States

Site Status

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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San Diego, California, United States

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Upland, California, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Groton, Connecticut, United States

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West Hartford, Connecticut, United States

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Inverness, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Savannah, Georgia, United States

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Idaho Falls, Idaho, United States

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Amite, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Marrero, Louisiana, United States

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Shreveport, Louisiana, United States

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Paw Paw, Michigan, United States

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Scottsbluff, Nebraska, United States

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Lawrenceville, New Jersey, United States

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Canfield, Ohio, United States

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Centerville, Ohio, United States

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Cleveland, Ohio, United States

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Zanesville, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Abington, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Sandy City, Utah, United States

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Spokane, Washington, United States

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Charleston, West Virginia, United States

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Huntington, West Virginia, United States

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Menomonee Falls, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21043553 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20859150 (View on PubMed)

Other Identifiers

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XP12B-MR-303

Identifier Type: -

Identifier Source: org_study_id

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