Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Placebo, 2 capsules daily for 3 months
Hospital Perinatal del Estado de Mexico del ISEM
Toluca, Estado de Mexico C.P., Mexico
Comité para la Prevención de la Osteoporosis COMOP
Mexico City, Federal District, Mexico
Centro Hospitalario Nuevo Sanatorio Durango
Mexico City, Federal District, Mexico
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
Time frame: 3 months
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Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"
Mexico City, Federal District, Mexico
Hospital de la Fe
San Miguel de Allende, Guanajuato, Mexico
Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)
Monterrey, Nuevo León, Mexico
MIRC (Monterrey International Research Center)
Monterrey, Nuevo León, Mexico