Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
- Registration Number
- NCT01553123
- Lead Sponsor
- Watson Pharmaceuticals
- 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.
- Detailed Description
This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ulipristal with iron Ulipristal Acetate - Ulipristal with iron Iron - Placebo Iron Placebo with iron
- Primary Outcome Measures
Name Time Method 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. Change from baseline in hemoglobin levels (g/dL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Discovery Clinical Trials - Genesis Health Central Women's Care
🇺🇸Dallas, Texas, United States
Lawrence Obstetrics-Gynecology Clinical Research
🇺🇸Lawrenceville, New Jersey, United States
Columbus Center for Women's Health Research
🇺🇸Columbus, Ohio, 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
Advances in Health Inc
🇺🇸Houston, Texas, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Hutzel Womens Health Specialists
🇺🇸Detroit, Michigan, United States
Clinical Trials of Texas Incorporated Laboratory
🇺🇸San Antonio, Texas, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Healthcare Clinical Data, Inc.
🇺🇸North Miami, Florida, United States
South Bend Clinical
🇺🇸Granger, Indiana, United States
Benchmark Research
🇺🇸Sacramento, California, United States
Coastal Clinical Research, Inc
🇺🇸Mobile, Alabama, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Atlanta Women's Research Institute, Inc
🇺🇸Atlanta, Georgia, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Fellows Research Alliance
🇺🇸Savannah, Georgia, United States
Women's Health Practice
🇺🇸Champaign, Illinois, United States
All Women's Healthcare of West Broward
🇺🇸Plantation, Florida, United States
Physician Care Clinical Research, LLC
🇺🇸Sarasota, Florida, United States
Praetorian Pharmaceutical Research, LLC
🇺🇸Marrero, Louisiana, United States
Center for Women's Research
🇺🇸Palos Heights, Illinois, United States
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Women Under Study, LLC
🇺🇸New Orleans, Louisiana, United States
Advanced Gynecologic Surgery Institute
🇺🇸Naperville, Illinois, United States
New York Center for Women's Health Research
🇺🇸New York City, New York, United States
Women's Clinic of Lincoln, P.C.
🇺🇸Lincoln, Nebraska, United States
Carolina Women's Research and Wellness Center
🇺🇸Durham, North Carolina, United States
Southwest Clinical Research
🇺🇸Albuquerque, New Mexico, United States
Physicians for Women of Greensboro
🇺🇸Greensboro, North Carolina, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Hawthorne Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Southeast Regional Research Group
🇺🇸Aiken, South Carolina, United States
Advanced Clinical Concepts
🇺🇸West Reading, Pennsylvania, United States
South Carolina Clinical Research Center, LLC
🇺🇸Columbia, South Carolina, United States
Willowbend Health and Wellness Associates
🇺🇸Plano, Texas, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States