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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


Phase 3
18 Years
48 Years
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Andre vanAs, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Repros Therapeutics Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ZPU-304

NCT ID:

NCT00853567

Start Date:

February 2009

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Advanced Clinical Research InstituteAnaheim, California  92801
Comprehensive Clinical Trials, LLCWest Palm Beach, Florida  33409
HWC Women's Research CenterMiamisburg, Ohio  45342
National Institute of Clinical ResearchLos Angeles, California  90017
Segal Institute for Clinical ResearchNorth Miami, Florida  33161
Impact Clinical TrialsLos Angeles, California  90057
Clinical Trials Select (ecast)Decatur, Georgia  30030
Medical Network for Education and ResearchDecatur, Georgia  30333
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)Decatur, Georgia  30035
Bluegrass Clinical Research, Inc.Louisville, Kentucky  40291
Central Brooklyn Medical Group (eCast)Brooklyn, New York  11205
Chattanooga Medical Research, LLCChattanooga, Tennessee  37404
Phoenix Women's Center (eCast0College Park, Georgia  30349
Smith & Hackney (eCast)Morrow, Georgia  30260
Rapid Medical Research, Inc. (Elite)Cleveland, Ohio  44122
Center for Women's MedicineHouston, Texas  77079