Anemia Clinical Trial
Official title:
A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Eligible female subjects will be randomly assigned to one of the three treatment groups.
Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily
during study drug treatment. The study duration is approximately six months, which is
comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a
one-month follow-up period.
Study was terminated by clinical hold.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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