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A Phase III, Open Label, Two-Arm, Parallel Design, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex® (CDB-4124) to Assess Recurrence of Symptoms in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids


Phase 3
18 Years
N/A
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

A Phase III, Open Label, Two-Arm, Parallel Design, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex® (CDB-4124) to Assess Recurrence of Symptoms in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids


Inclusion Criteria:



- At least one uterine fibroid must be identifiable and measurable by Transvaginal
Ultrasound (TVU)

- Subject must have uterine fibroid-associated symptoms during the-screening visit

- Subject has menstrual cycle lasting from 20 to 40 days

- Other inclusion criteria may apply

Exclusion Criteria:

- Post-menopausal women or women likely to become post-menopausal during the study

- Subject with a significant organ abnormality or disease (based on the Investigator's
judgment) that would in the opinion of the Investigator exclude the subject from
participating

- Subject with any medical condition that, in the opinion of the Investigator, is not
compatible with study procedures or which would prevent the subject from starting or
completing the study, or interfere with the subject participating in this study.

- Subject who has had an acute illness within five days of study medication
administration

- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically

- Subject with an abnormal screening endometrial biopsy including the presence of
Endometrial Intraepithelial Neoplasia (EIN)

- Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at
screening

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 evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles

Outcome Time Frame:

Four months each cycle

Safety Issue:

Yes

Principal Investigator

Andre van As, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Repros Therapeutics Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ZPU-306

NCT ID:

NCT00874302

Start Date:

Completion Date:

Related Keywords:

  • Uterine Fibroids
  • Uterine fibroids
  • Leiomyoma
  • Myofibroma
  • Recurrence

Name

Location

Meharry Medical CollegeNashville, Tennessee  37208-3599
Lyndhurst Gynecologic AssociatesWinston-Salem, North Carolina  27103
Clinical Trials of AmericaEugene, Oregon  97401
Genesis Center for Clinical ResearchSan Diego, California  92103
Physician Care Clinical Research, LLCSarasota, Florida  34329
Soapstone Center for Clinical ResearchDecatur, Georgia  30034
York Clinical ConsultingMarrero, Louisiana  70072
Female Pelvic MedicineGrand Rapids, Michigan  49503
Hawthorne Medical Research, Inc.Winston-Salem, North Carolina  27103
Thomas Jefferson University - Jefferson Center for Women's Medical SpecialtiesPhiladelphia, Pennsylvania  19107-5127
Women's Care Center, PLC Research Memphis AssociatesMemphis, Tennessee  38119
Willowbend Health & Wellness AssociatesPlano, Texas  75093
Atlanta Women's Research Inst.Atlanta, Georgia  30342