Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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:
NCT00735553
First received: August 13, 2008
Last updated: June 23, 2014
Last verified: June 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®
Drug: 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 ]
  • 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 Uterine Fibroid Symptom Quality of Life (UFS-QOL) severity score. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
25 mg oral daily dose of Proellex®;
Drug: Proellex®
One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
Active Comparator: 2
50 mg oral daily dose of Proellex®
Drug: Proellex®
Two 25 mg mg capsules of Proellex® orally daily for up to four months
Placebo Comparator: 3
oral daily dose of placebo
Drug: Placebo
Two placebo capsules orally daily for up to four months

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: NCT00735553

Locations
United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
United States, Arizona
Women's Health Research
Phoenix, Arizona, United States, 85015
Genova Clinical Research, Inc.
Tucson, Arizona, United States, 85741
United States, California
Women's Health Care at Frost Steet
San Diego, California, United States, 92123
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80218
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
OB-GYN Associates of Mid-Florida, P.A.
Leesburg, Florida, United States, 34748
Miami Research Associates
Miami, Florida, United States, 33143
Insignia Clinical Research
Tampa, Florida, United States, 33613
United States, South Carolina
SC Clinical Research Center
Columbia, South Carolina, United States, 29201
United States, Texas
Advanced Research Associates
Corpus Christi, Texas, United States, 78414
The Woman's Hospital of Texas, Clinical Research Center
Houston, Texas, United States, 77054
Advances in Health Inc.
Houston, Texas, United States, 77030
Institute for Women's Health
San Antonio, Texas, United States, 78229
Seven Oaks Women's Ctr.
San Antonio, Texas, United States, 78229
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: NCT00735553     History of Changes
Other Study ID Numbers: ZPU-303
Study First Received: August 13, 2008
Last Updated: June 23, 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 July 20, 2014