Study Stopped
Repros stopped study for safety and FDA put study on hold.
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
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
1 other identifier
interventional
175
1 country
25
Brief Summary
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2008
Shorter than P25 for phase_3
25 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
First Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedStudy Start
First participant enrolled
October 1, 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
10 months
August 14, 2008
June 25, 2014
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
12 months
Study Arms (2)
25 mg Proellex
ACTIVE COMPARATORProellex 25 mg once daily
Proellex 50 mg
ACTIVE COMPARATORProellex 50 mg once daily
Interventions
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
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 (25)
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
AWC Clinical Trials LLC
Little Rock, Arkansas, 72223, United States
Impact Clinical Trials
Beverly Hills, California, 80211, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, 34329, United States
Atlanta Women's Research Inst
Atlanta, Georgia, 30342, United States
Medical Network for Education and Research
Decatur, Georgia, 30033, United States
Soapstone Center for Clinical Research
Decatur, Georgia, 30034, United States
York Clinical Consulting
Marrero, Louisiana, 70072, United States
NECCR Falls River LLC
Fall River, Massachusetts, 02720, United States
ClinSite, LLC
Ann Arbor, Michigan, 48106, United States
Female Pelvic Medicine
Grand Rapids, Michigan, 49503, United States
Alegent Research
Omaha, Nebraska, 68124, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103, United States
Clinical Trials of America
Eugene, Oregon, 97408, United States
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
Philadelphia, Pennsylvania, 19107-5127, United States
University Medical Group, Dept of OB/GYN
Greenville, South Carolina, 29605, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, 29615, United States
Memphis Women's Healthcare
Memphis, Tennessee, 38119, United States
Women's Care Center, PLC Research Memphis Associates
Memphis, Tennessee, 38119, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Women Partners in Health
Austin, Texas, 78705, United States
Willowbend Health & Wellness Associates
Plano, Texas, 75093, United States
Medical Associates Inc.
Menomonee Falls, Wisconsin, 53051, United States
MeSH Terms
Conditions
Interventions
Condition 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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 18, 2008
Study Start
October 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