A Study of the Safety and Efficacy of Intermittent Ulipristal Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 50
Updated:11/9/2017
Start Date:January 29, 2014
End Date:January 3, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment
of bleeding associated with uterine fibroids


Inclusion Criteria:

- Cyclic abnormal uterine bleeding (heavy or prolonged).

- Menstrual blood loss (MBL) of ≥ 80 mL in the first 8 days of menses.

- Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

Exclusion Criteria:

- Evidence of malignancy or atypical or non-atypical hyperplasia on endometrial biopsy.
We found this trial at
56
sites
Watson Investigational Site
Albuquerque, New Mexico
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Albuquerque, NM
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Atlanta, Georgia
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Atlanta, GA
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Bluffton, South Carolina
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Bluffton, SC
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Boynton Beach, Florida
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Boynton Beach, FL
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Brownsburg, Indiana 46112
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Brownsburg, IN
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Champaign, Illinois
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Champaign, IL
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Charleston, South Carolina
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Charleston, SC
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Clearwater, Florida
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Clearwater, FL
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Cleveland, Ohio
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Cleveland, OH
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Columbia, South Carolina
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Columbia, SC
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Dallas, Texas
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Dallas, TX
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Denver, Colorado
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Denver, CO
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Durham, North Carolina
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Durham, NC
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Englewood, Ohio
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Englewood, OH
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Frisco, Texas
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Frisco, TX
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Granger, Indiana
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Granger, IN
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Greensboro, North Carolina
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Greensboro, NC
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Watson Investigational Site 154
Greenville, South Carolina 29615
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Greenville, SC
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Watson Investigational Site 140
Hamilton, Ontario
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Hamilton,
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Watson Investigational Site 157
Hawaiian Gardens, California 90716
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Hawaiian Gardens, CA
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Watson Investigational Site
Houston, Texas
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Houston, TX
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La Mesa, California
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La Mesa, CA
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Las Vegas, Nevada
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Las Vegas, NV
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Las Vegas, Nevada
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Lawrenceville, New Jersey
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Lawrenceville, NJ
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Watson Investigational Site 150
Mandeville, Louisiana 70471
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Mandeville, LA
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Watson Investigational Site 155
Mayfield Heights, Ohio 44124
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Mayfield Heights, OH
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Mesa, Arizona
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Mesa, AZ
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Metairie, Louisiana
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Metairie, LA
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Miramar, Florida
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Miramar, FL
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Watson Investigational Site 158
Moorestown, New Jersey 08057
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Moorestown, NJ
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Watson Investigational Site
New Bern, North Carolina
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New Bern, NC
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New Orleans, Louisiana
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New Orleans, LA
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Norfolk, Virginia
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Norfolk, VA
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Norfolk, Virginia
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Norfolk, VA
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North Miami, Florida
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North Miami, FL
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Watson Investigational Site
Orlando, Florida 32801
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Orlando, FL
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Phoenix, Arizona
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Phoenix, AZ
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Phoenix, Arizona
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Pittsburgh, Pennsylvania 15206
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Pittsburgh, PA
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Watson Investigational Site
Plantation, Florida
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Plantation, FL
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Watson Investigational Site
Raleigh, North Carolina 27612
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Raleigh, NC
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San Antonio, Texas
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San Antonio, TX
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San Diego, California
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San Diego, CA
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San Diego, California
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Sandy Springs, Georgia
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Sandy Springs, GA
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Sarasota, Florida
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Sarasota, FL
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Savannah, Georgia
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Savannah, GA
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Schaumburg, Illinois
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Schaumburg, IL
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Seattle, Washington
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Tucson, Arizona
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Webster, Texas
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Webster, TX
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West Palm Beach, Florida
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Watson Investigational Site 105
West Reading, Pennsylvania 19611
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Winston-Salem, North Carolina
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Winston-Salem, NC
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