Study Stopped
Repros stopped the study for safety and FDA put the study on hold for safety.
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
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
1 other identifier
interventional
77
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 13, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedAugust 21, 2014
August 1, 2014
1 year
August 13, 2008
June 25, 2014
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
4 months
Study Arms (3)
25 mg Proellex
ACTIVE COMPARATOR25 mg oral daily dose of Proellex
50 mg Proellex
ACTIVE COMPARATOR50 mg oral daily dose of Proellex
placebo
PLACEBO COMPARATORoral daily dose of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Genova Clinical Research, Inc.
Tucson, Arizona, 85741, United States
Women's Health Care at Frost Steet
San Diego, California, 92123, United States
Downtown Women's Health Care
Denver, Colorado, 80218, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
OB-GYN Associates of Mid-Florida, P.A.
Leesburg, Florida, 34748, United States
Miami Research Associates
Miami, Florida, 33143, United States
Insignia Clinical Research
Tampa, Florida, 33613, United States
SC Clinical Research Center
Columbia, South Carolina, 29201, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Advances in Health Inc.
Houston, Texas, 77030, United States
The Woman's Hospital of Texas, Clinical Research Center
Houston, Texas, 77054, United States
Institute for Women's Health
San Antonio, Texas, 78229, United States
Seven Oaks Women's Ctr.
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.
Results Point of Contact
- Title
- Jennifer Wike
- Organization
- Repros Therapeutics Inc.
Study Officials
- STUDY DIRECTOR
Andre vanAs, MD, PhD
Repros Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2008
First Posted
August 15, 2008
Study Start
August 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 21, 2014
Results First Posted
August 21, 2014
Record last verified: 2014-08