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

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

Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

Study Overview

• Status: Terminated
• Conditions: Anemia; Uterine Fibroids
• Intervention / Treatment: Drug: Proellex 25 mg; Drug: Proellex 50 mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Estado de Mexico C.P.
    • Toluca, Estado de Mexico C.P., Mexico, 50120
      • Hospital Perinatal del Estado de Mexico del ISEM
  • Federal District
    • Mexico City, Federal District, Mexico, 06100
      • Comité para la Prevención de la Osteoporosis COMOP
    • Mexico City, Federal District, Mexico, 06700
      • Centro Hospitalario Nuevo Sanatorio Durango
    • Mexico City, Federal District, Mexico, 11000
      • Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"
  • Gto
    • San Miguel de Allende, Gto, Mexico, 37775
      • Hospital de la Fe
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)
    • Monterrey, Nuevo León, Mexico, 64460
      • MIRC (Monterrey International Research Center)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo, 2 capsules daily for 3 months; Other Names: Sugar pill; Dummy
Experimental: Proellex 50 mg	Drug: Proellex 50 mg; Proellex 50 mg, 2 - 25 mg capsules daily for 3 months; Other Names: Telapristone acetate
Experimental: 25 mg Proellex; Proellex 25 mg	Drug: Proellex 25 mg; Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months; Other Names: Telapristone acetate

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.
• Investigators: Study Director: Andre van As, MD, PhD, Repros Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: November 3, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Estimate): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Anemia; Uterine fibroids
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: ZPU-302