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
Verified date | August 2014 |
Source | Repros Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
Status | Terminated |
Enrollment | 8 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
Inclusion Criteria: - Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive; - Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding; - Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study; - Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits Exclusion Criteria: - Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following: - Six months or more (immediately prior to Screening Visit) without a menstrual period, or - Prior hysterectomy, or - Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring); - Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause; - Documented endometriosis or active pelvic inflammatory disease (PID); - Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs; - Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia; - Use of prohibited concomitant medications: 1. Depo-Provera use must cease ten months prior to first dose of study drug, or 2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or 3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Centro Hospitalario Nuevo Sanatorio Durango | Mexico City | Federal District |
Mexico | Comité para la Prevención de la Osteoporosis COMOP | Mexico City | Federal District |
Mexico | Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes" | Mexico City | Federal District |
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 | Hospital de la Fe | San Miguel de Allende | Gto |
Mexico | Hospital Perinatal del Estado de Mexico del ISEM | Toluca | Estado de Mexico C.P. |
Lead Sponsor | Collaborator |
---|---|
Repros Therapeutics Inc. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months. | 3 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
Completed |
NCT01458028 -
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
|
Phase 1 | |
Terminated |
NCT01535781 -
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
|
N/A |