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A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg 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, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids


Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio.
Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each
treatment cycle being separated by an off-drug interval until menstruation occurs. During
the treatment periods, all subjects will be assessed monthly. Subjects will undergo an
additional follow-up for 3 months following their last treatment visit.


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.

Additional inclusion criteria may apply.

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.

Additional exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of Proellex administered once daily for three treatment cycles (4 months each cycle)

Outcome Time Frame:

12 months

Safety Issue:

Yes

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-305

NCT ID:

NCT00737282

Start Date:

October 2008

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Meharry Medical CollegeNashville, Tennessee  37208-3599
Lyndhurst Gynecologic AssociatesWinston-Salem, North Carolina  27103
Impact Clinical TrialsLos Angeles, California  90057
Medical Network for Education and ResearchDecatur, Georgia  30333
Clinical Trials of AmericaEugene, Oregon  97401
Lynn Institute of the OzarksLittle Rock, Arkansas  72205
AWC Clinical Trials LLCLittle Rock, Arkansas  72223
Genesis Center for Clinical ResearchSan Diego, California  92103
Physician Care Clinical Research, LLCSarasota, Florida  34329
Atlanta Women's Research InstAtlanta, Georgia  30342
Soapstone Center for Clinical ResearchDecatur, Georgia  30034
York Clinical ConsultingMarrero, Louisiana  70072
NECCR Falls River LLCFall River, Massachusetts  02720
ClinSite, LLCAnn Arbor, Michigan  48106
Female Pelvic MedicineGrand Rapids, Michigan  49503
Alegent ResearchOmaha, Nebraska  68124
Hawthorne Medical Research, Inc.Winston-Salem, North Carolina  27103
Thomas Jefferson University - Jefferson Center for Women's Medical SpecialtiesPhiladelphia, Pennsylvania  19107-5127
Greenville Pharmaceutical ResearchGreenville, South Carolina  29615
University Medical Group, Dept of OB/GYNGreenville, South Carolina  29605
Women's Care Center, PLC Research Memphis AssociatesMemphis, Tennessee  38119
Memphis Women's HealthcareMemphis, Tennessee  38119
Women Partners in HealthAustin, Texas  78705
Willowbend Health & Wellness AssociatesPlano, Texas  75093
Medical Associates Inc.Menomonee Falls, Wisconsin  53051