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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-303

NCT ID:

NCT00735553

Start Date:

August 2008

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Alabama Clinical TherapeuticsBirmingham, Alabama  35235
Visions Clinical ResearchBoynton Beach, Florida  33472
Insignia Clinical ResearchTampa, Florida  33613
Miami Research AssociatesMiami, Florida  33173
Women's Health ResearchPhoenix, Arizona  85015
Genova Clinical Research, Inc.Tucson, Arizona  85741
Downtown Women's Health CareDenver, Colorado  80218
OB-GYN Associates of Mid-Florida, P.A.Leesburg, Florida  34748
SC Clinical Research CenterColumbia, South Carolina  29201
Advanced Research AssociatesCorpus Christi, Texas  78414
Advances in Health Inc.Houston, Texas  77030
Institute for Women's HealthSan Antonio, Texas  78229
Women's Health Care at Frost SteetSan Diego, California  92123
The Woman's Hospital of Texas, Clinical Research CenterHouston, Texas  77054
Seven Oaks Women's Ctr.San Antonio, Texas  78229