Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids

Phase 3

Terminated

• Conditions: Anemia; Uterine Fibroids
• Interventions: Drug: Proellex 25 mg; Drug: Proellex 50 mg; Drug: Placebo

• Registration Number: NCT00785356
• Lead Sponsor: Repros Therapeutics Inc.

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2014-06-25
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Results First Posted: 2014-08-21
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg Proellex	Proellex 25 mg	Proellex 25 mg
Proellex 50 mg	Proellex 50 mg	Proellex 50 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.	3 months

Trial Locations

Locations (7)

Comité para la Prevención de la Osteoporosis COMOP; 🇲🇽 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

Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"; 🇲🇽 Mexico City, Federal District, Mexico

Hospital de la Fe; 🇲🇽 San Miguel de Allende, Gto, Mexico

MIRC (Monterrey International Research Center); 🇲🇽 Monterrey, Nuevo León, Mexico

Hospital Perinatal del Estado de Mexico del ISEM; 🇲🇽 Toluca, Estado de Mexico C.P., Mexico

Centro Hospitalario Nuevo Sanatorio Durango; 🇲🇽 Mexico City, Federal District, Mexico