Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
NCT ID: NCT01553123
Last Updated: 2013-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-04-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ulipristal with iron
Ulipristal Acetate
once daily, oral
Iron
once daily, dried ferrous sulfate
Placebo
Placebo with iron
Iron
once daily, dried ferrous sulfate
Interventions
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Ulipristal Acetate
once daily, oral
Iron
once daily, dried ferrous sulfate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has documented leiomyoma(s);
* Has leiomyoma-related anemia;
* Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia;
* Is willing and able to provide written informed consent and authorization to disclose protected health information.
Exclusion Criteria
* Has a condition requiring immediate or intermittent blood transfusions;
* Has a known coagulation disorder;
* Has a history of uterine, cervix, ovarian, or breast cancer;
* Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months;
* Has received blood transfusion within 8 weeks before the screening visit;
* Has abnormal liver functions;
* Is pregnant.
18 Years
50 Years
FEMALE
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Zobrist, MS, PhD
Role: STUDY_DIRECTOR
Watson Pharmaceuticals
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Coastal Clinical Research, Inc
Mobile, Alabama, United States
Women's Health Research
Phoenix, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
Benchmark Research
Sacramento, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, United States
All Women's Healthcare of West Broward
Plantation, Florida, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Atlanta Women's Research Institute, Inc
Atlanta, Georgia, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Fellows Research Alliance
Savannah, Georgia, United States
Women's Health Practice
Champaign, Illinois, United States
Advanced Gynecologic Surgery Institute
Naperville, Illinois, United States
Center for Women's Research
Palos Heights, Illinois, United States
South Bend Clinical
Granger, Indiana, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, United States
Women Under Study, LLC
New Orleans, Louisiana, United States
Hutzel Womens Health Specialists
Detroit, Michigan, United States
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, United States
Office of Annette Mayes, MD, PC
Las Vegas, Nevada, United States
Office of Edmond Pack, MD
Las Vegas, Nevada, United States
Office of R. Garn Mabey, Jr
Las Vegas, Nevada, United States
Lawrence Obstetrics-Gynecology Clinical Research
Lawrenceville, New Jersey, United States
Southwest Clinical Research
Albuquerque, New Mexico, United States
New York Center for Women's Health Research
New York, New York, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
Physicians for Women of Greensboro
Greensboro, North Carolina, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Hawthorne Medical Research
Winston-Salem, North Carolina, United States
Columbus Center for Women's Health Research
Columbus, Ohio, United States
Advanced Clinical Concepts
West Reading, Pennsylvania, United States
Southeast Regional Research Group
Aiken, South Carolina, United States
South Carolina Clinical Research Center, LLC
Columbia, South Carolina, United States
Discovery Clinical Trials - Genesis Health Central Women's Care
Dallas, Texas, United States
Advances in Health Inc
Houston, Texas, United States
Willowbend Health and Wellness Associates
Plano, Texas, United States
Clinical Trials of Texas Incorporated Laboratory
San Antonio, Texas, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Countries
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Other Identifiers
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UL1104
Identifier Type: -
Identifier Source: org_study_id
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