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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
once daily, oral
once daily, dried ferrous sulfate
Change from baseline in hemoglobin levels (g/dL)
Change from baseline in hemoglobin levels (g/dL)
Time frame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
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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
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