Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

August 5, 2014 updated by: Repros Therapeutics Inc.

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

Intervention / Treatment

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)

71

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Los Angeles, California, United States, 90057
        • Impact Clinical Trials
      • Los Angeles, California, United States, 90057
        • National Institute of Clinical Research
      • Los Angeles, California, United States, 90211
        • Impact Clinical Trials
    • Florida
      • Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • College Park, Georgia, United States, 30349
        • Phoenix Women's Center (eCast0
      • Decatur, Georgia, United States, 30030
        • Clinical Trials Select (eCast)
      • Decatur, Georgia, United States, 30035
        • Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
      • Decatur, Georgia, United States, 30333
        • Medical Network for Education and Research
      • Morrow, Georgia, United States, 30260
        • Smith & Hackney (eCast)
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research, Inc.
    • New York
      • Brooklyn, New York, United States, 11205
        • Central Brooklyn Medical Group (eCast)
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc. (Elite)
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research, Llc
    • Texas
      • Houston, Texas, United States, 77079
        • Center for Women's Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo treatment
Other: placebo
Placebo
ACTIVE_COMPARATOR: 25 g Proellex
25 mg oral daily dose of Proellex
Drug: Proellex
25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
Other Names:
  • Telapristone acetate
ACTIVE_COMPARATOR: 50 mg Proellex
50 mg oral daily dose of Proellex
Drug: Proellex
25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
Other Names:
  • Telapristone acetate

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)
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (ESTIMATE)

March 2, 2009

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPU-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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