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

This study has been terminated.
(Repros stopped the study for safety and FDA put the study on hold for safety.)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00853567
First received: February 27, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Drug: Proellex
Other: placebo
Phase 3

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

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 25 g Proellex
25 mg oral daily dose of Proellex
Drug: Proellex
25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
Other Name: Telapristone acetate
Active Comparator: 50 mg Proellex
50 mg oral daily dose of Proellex
Drug: Proellex
25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
Other Name: Telapristone acetate
Placebo Comparator: Placebo
Placebo treatment
Other: placebo
Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853567

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
National Institute of Clinical Research
Los Angeles, California, United States, 90057
Impact Clinical Trials
Los Angeles, California, United States, 90211
Impact Clinical Trials
Los Angeles, California, United States, 90057
United States, Florida
Segal Institute for Clinical Research
Miami, Florida, United States, 33161
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409
United States, Georgia
Phoenix Women's Center (eCast0
College Park, Georgia, United States, 30349
Medical Network for Education and Research
Decatur, Georgia, United States, 30333
Clinical Trials Select (eCast)
Decatur, Georgia, United States, 30030
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
Decatur, Georgia, United States, 30035
Smith & Hackney (eCast)
Morrow, Georgia, United States, 30260
United States, Kentucky
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
United States, New York
Central Brooklyn Medical Group (eCast)
Brooklyn, New York, United States, 11205
United States, Ohio
Rapid Medical Research, Inc. (Elite)
Cleveland, Ohio, United States, 44122
HWC Women's Research Center
Englewood, Ohio, United States, 45322
United States, Tennessee
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States, 37404
United States, Texas
Center for Women's Medicine
Houston, Texas, United States, 77079
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAs, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00853567     History of Changes
Other Study ID Numbers: ZPU-304
Study First Received: February 27, 2009
Results First Received: June 25, 2014
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine Fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 28, 2014