Spots Global Cancer Trial Database for Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
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Trial Identification
Brief Title: Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
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
Study ID: NCT00785356
Study Description
Brief Summary: Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes", Mexico City, Federal District, Mexico
Hospital de la Fe, San Miguel de Allende, Gto, 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
Contact Details
Name: Andre van As, MD, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
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