Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

A Phase III, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Proellex; Drug: Proellex; Drug: Placebo

Detailed Description

Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research
    • Tucson, Arizona, United States, 85741
      • Genova Clinical Research, Inc.
  • California
    • San Diego, California, United States, 92123
      • Women's Health Care at Frost Steet
  • Colorado
    • Denver, Colorado, United States, 80218
      • Downtown Women's Health Care
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Visions Clinical Research
    • Leesburg, Florida, United States, 34748
      • OB-GYN Associates of Mid-Florida, P.A.
    • Miami, Florida, United States, 33143
      • Miami Research Associates
    • Tampa, Florida, United States, 33613
      • Insignia Clinical Research
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • SC Clinical Research Center
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Advanced Research Associates
    • Houston, Texas, United States, 77030
      • Advances in Health Inc.
    • Houston, Texas, United States, 77054
      • The Woman's Hospital of Texas, Clinical Research Center
    • San Antonio, Texas, United States, 78229
      • Institute for Women's Health
    • San Antonio, Texas, United States, 78229
      • Seven Oaks Women's Ctr.

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:

• Speak, read and understand English or Spanish;
• Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
• One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
• Menstrual cycle lasting from 24 to 36 days;
• History of excessive menstrual bleeding;
• Negative urine pregnancy test at screening.

Exclusion Criteria:

• Six months or more (immediately prior to Screening Visit) without a menstrual period;
• Prior hysterectomy;
• Prior bilateral oophorectomy;
• Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
• Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
• Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
• Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
• Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

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
Active Comparator: 25 mg Proellex; 25 mg oral daily dose of Proellex	Drug: Proellex; One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months; Other Names: Telapristone acetate; Drug: Proellex; Two 25 mg mg capsules of Proellex® orally daily for up to four months; Other Names: Telapristone acetate
Active Comparator: 50 mg Proellex; 50 mg oral daily dose of Proellex	Drug: Proellex; One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months; Other Names: Telapristone acetate; Drug: Proellex; Two 25 mg mg capsules of Proellex® orally daily for up to four months; Other Names: Telapristone acetate
Placebo Comparator: placebo; oral daily dose of placebo	Drug: Placebo; Two placebo capsules orally daily for up to four months; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)	4 months

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 15, 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: 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-303