Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Study Overview

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

Detailed Description

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72223
      • AWC Clinical Trials LLC
  • California
    • Beverly Hills, California, United States, 80211
      • Impact Clinical Trials
    • San Diego, California, United States, 92103
      • Genesis Center for Clinical Research
  • Florida
    • Sarasota, Florida, United States, 34329
      • Physician Care Clinical Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Research Inst
    • Decatur, Georgia, United States, 30034
      • Soapstone Center for Clinical Research
    • Decatur, Georgia, United States, 30033
      • Medical Network for Education and Research
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • York Clinical Consulting
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • NECCR Falls River LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • ClinSite, LLC
    • Grand Rapids, Michigan, United States, 49503
      • Female Pelvic Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Alegent Research
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Hawthorne Medical Research, Inc.
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Gynecologic Associates
  • Oregon
    • Eugene, Oregon, United States, 97408
      • Clinical Trials Of America
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-5127
      • Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Pharmaceutical Research
    • Greenville, South Carolina, United States, 29605
      • University Medical Group, Dept of OB/GYN
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Memphis Women's Healthcare
    • Memphis, Tennessee, United States, 38119
      • Women's Care Center, PLC Research Memphis Associates
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College
  • Texas
    • Austin, Texas, United States, 78705
      • Women Partners in Health
    • Plano, Texas, United States, 75093
      • Willowbend Health & Wellness Associates
  • Wisconsin
    • Menomonee Falls, Wisconsin, United States, 53051
      • Medical Associates Inc.

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.

Additional inclusion criteria may apply.

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.

Additional exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 25 mg Proellex; Proellex 25 mg once daily	Drug: Proellex 25 mg; One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle; Other Names: Telapristone acetate
Active Comparator: Proellex 50 mg; Proellex 50 mg once daily	Drug: Proellex 50 mg; Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle; Other Names: Telapristone acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)	12 months

Collaborators and Investigators

• Sponsor: 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: August 14, 2008
• First Submitted That Met QC Criteria: August 15, 2008
• First Posted (Estimate): August 18, 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-305