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

August 5, 2014 updated by: Repros Therapeutics Inc.

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

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 Overview

Status

Terminated

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 was terminated by clinical hold.

Study Type

Interventional

Enrollment (Actual)

56

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

    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
    • 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, 90057
        • Impact Clinical Trials
    • 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, 33161
        • Segal Institute for Clinical Research
      • Tampa, Florida, United States, 33607
        • Insignia Clinical Research (Tampa Bay Women's Center)
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • College Park, Georgia, United States, 30349
        • Phoenix Women's Center (eCast)
      • 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
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research, Inc.
    • Maryland
      • Silver Spring, Maryland, United States, 20903
        • Clinical Trials Select (eCast)
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Phoenix OB-GYN Associates, LLC
    • 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
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • SC Clinical Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research, LLC
    • 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 Women's Hospital of Texas, Clinical Research Center
      • Houston, Texas, United States, 77079
        • Centex Research
      • San Antonio, Texas, United States, 78229
        • Seven Oaks Women's Center
      • San Antonio, Texas, United States, 78229
        • Institute for Women's Health

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 45 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

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
EXPERIMENTAL: A 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
EXPERIMENTAL: B 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
PLACEBO_COMPARATOR: C Placebo
Placebo, 2 capsules daily for 3 months
Placebo, 2 capsules daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin vs Placebo
Time Frame: 3 months
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
3 months

Collaborators and Investigators

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

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

June 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (ESTIMATE)

June 20, 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

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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