Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
Withdrawn before enrolling · Phase 3 · Has a placebo group
Conditions studied: Leiomyomas
In brief
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.
Key facts
- Study ID
- NCT01553123
- Run by
- Watson Pharmaceuticals
- People needed
- 0
- Starts
- 2012-04-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2013-02-07
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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