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

Last updated: August 5, 2014
Sponsor: Repros Therapeutics Inc.
Overall Status: Terminated

Phase

3

Condition

Uterine Fibroids

Uterina Myoma

Desmoid Tumors

Treatment

N/A

Clinical Study ID

NCT00853567
ZPU-304
  • Ages 18-48
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Speak, read and understand English or Spanish;

  • Not have undergone hysterectomy, uterine arterial embolization or endometrial ablationtherapy (previous myomectomy is acceptable) for any cause and no surgicalinterventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterialembolization) 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

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 becomepregnant at any time during the study;

  • Documented endometriosis, active pelvic inflammatory disease (PID), plateletdysfunction, or Von Willebrand's Disease;

  • Any history or diagnosis of gynecological cancer or cervical dysplasia of any gradeincluding atypical squamous cells of undetermined significance (ASCUS) associated withHuman Papilloma Virus (HPV);

  • Subject with diagnosed or suspected carcinoma of the breast, reproductive organs orany other organ system;

  • Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, orChlamydia or previous history of auto-immune disease or positive serum antinuclearantibodies.

Study Design

Total Participants: 71
Study Start date:
February 01, 2009
Estimated Completion Date:
August 31, 2009

Study 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.

Connect with a study center

  • Advanced Clinical Research Institute

    ,Anaheim, California 92801
    United States

    Site Not Available

  • Advanced Clinical Research Institute

    Anaheim, California 92801
    United States

    Site Not Available

  • Impact Clinical Trials

    Los Angeles, California 90057
    United States

    Site Not Available

  • National Institute of Clinical Research

    Los Angeles, California 90057
    United States

    Site Not Available

  • Segal Institute for Clinical Research

    Miami, Florida 33161
    United States

    Site Not Available

  • Comprehensive Clinical Trials, LLC

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Phoenix Women's Center (eCast0

    College Park, Georgia 30349
    United States

    Site Not Available

  • Clinical Trials Select (eCast)

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)

    Decatur, Georgia 30035
    United States

    Site Not Available

  • Medical Network for Education and Research

    Decatur, Georgia 30333
    United States

    Site Not Available

  • Smith & Hackney (eCast)

    Morrow, Georgia 30260
    United States

    Site Not Available

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • Central Brooklyn Medical Group (eCast)

    Brooklyn, New York 11205
    United States

    Site Not Available

  • Rapid Medical Research, Inc. (Elite)

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • HWC Women's Research Center

    Englewood, Ohio 45322
    United States

    Site Not Available

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Center for Women's Medicine

    Houston, Texas 77079
    United States

    Site Not Available

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