Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas
1 other identifier
interventional
N/A
1 country
47
Brief Summary
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2012
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 7, 2013
February 1, 2013
1.6 years
March 2, 2012
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in hemoglobin levels (g/dL)
Change from baseline in hemoglobin levels (g/dL)
Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
Study Arms (2)
Ulipristal with iron
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo with iron
Interventions
Eligibility Criteria
You may qualify if:
- Is a pre-menopausal female, 18 - 50 years;
- 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.
You may not qualify if:
- Has a history of uterine surgery that would interfere with the study;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Coastal Clinical Research, Inc
Mobile, Alabama, 36608, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Visions Clinical Research
Tucson, Arizona, 85712, United States
Benchmark Research
Sacramento, California, 95816, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92101, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Downtown Women's Health Care
Denver, Colorado, 80218, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Altus Research
Lake Worth, Florida, 33461, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161, United States
All Women's Healthcare of West Broward
Plantation, Florida, 33324, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, 34321, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Atlanta Women's Research Institute, Inc
Atlanta, Georgia, 30342, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Fellows Research Alliance
Savannah, Georgia, 31406, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540, United States
Center for Women's Research
Palos Heights, Illinois, 60463, United States
South Bend Clinical
Granger, Indiana, 46530, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072, United States
Women Under Study, LLC
New Orleans, Louisiana, 70115, United States
Hutzel Womens Health Specialists
Detroit, Michigan, 48201, United States
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510, United States
Office of Annette Mayes, MD, PC
Las Vegas, Nevada, 89106, United States
Office of Edmond Pack, MD
Las Vegas, Nevada, 89106, United States
Office of R. Garn Mabey, Jr
Las Vegas, Nevada, 89128, United States
Lawrence Obstetrics-Gynecology Clinical Research
Lawrenceville, New Jersey, 08648, United States
Southwest Clinical Research
Albuquerque, New Mexico, 87102, United States
New York Center for Women's Health Research
New York, New York, 10038, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713, United States
Physicians for Women of Greensboro
Greensboro, North Carolina, 27408, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Hawthorne Medical Research
Winston-Salem, North Carolina, 27103, United States
Columbus Center for Women's Health Research
Columbus, Ohio, 43213, United States
Advanced Clinical Concepts
West Reading, Pennsylvania, 19611, United States
Southeast Regional Research Group
Aiken, South Carolina, 29803, United States
South Carolina Clinical Research Center, LLC
Columbia, South Carolina, 29201, United States
Discovery Clinical Trials - Genesis Health Central Women's Care
Dallas, Texas, 75231, United States
Advances in Health Inc
Houston, Texas, 77030, United States
Willowbend Health and Wellness Associates
Plano, Texas, 75093, United States
Clinical Trials of Texas Incorporated Laboratory
San Antonio, Texas, 78229, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Howard Zobrist, MS, PhD
Watson Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2012
First Posted
March 13, 2012
Study Start
April 1, 2012
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
February 7, 2013
Record last verified: 2013-02