Status:
TERMINATED
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Uterine Fibroids
Anemia
Eligibility:
FEMALE
18-48 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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:
- Depo-Provera use must cease ten months prior to first dose of study drug, or
- GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
- Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00785356
Start Date
October 1 2008
End Date
August 1 2009
Last Update
August 21 2014
Active Locations (7)
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1
Hospital Perinatal del Estado de Mexico del ISEM
Toluca, Estado de Mexico C.P., Mexico, 50120
2
Comité para la Prevención de la Osteoporosis COMOP
Mexico City, Federal District, Mexico, 06100
3
Centro Hospitalario Nuevo Sanatorio Durango
Mexico City, Federal District, Mexico, 06700
4
Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"
Mexico City, Federal District, Mexico, 11000