Study Stopped
Repros stopped study for safety and FDA put study on hold because of safety.
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
1 other identifier
interventional
56
1 country
30
Brief Summary
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
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 Jun 2008
Shorter than P25 for phase_3
30 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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 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
1.2 years
June 18, 2008
June 23, 2014
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin vs Placebo
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
3 months
Study Arms (3)
A 25 mg
EXPERIMENTALProellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
B 50 mg
EXPERIMENTALProellex 50 mg, 2 - 25 mg capsules daily for 3 months
C Placebo
PLACEBO COMPARATORPlacebo, 2 capsules daily for 3 months
Interventions
Eligibility Criteria
You may qualify if:
- Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
- Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
- Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
- Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
You may not qualify if:
- Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:
- Six months or more (immediately prior to Screening Visit) without a menstrual period, or
- Prior hysterectomy, or
- Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
- Documented endometriosis or active pelvic inflammatory disease (PID);
- Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
- Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
- Use of prohibited concomitant medications:
- Depo-Provera use must cease ten months prior to first dose of study drug, or
- GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
- Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Impact Clinical Trials
Los Angeles, California, 90057, United States
National Institute of Clinical Research
Los Angeles, California, 90057, 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
Segal Institute for Clinical Research
Miami, Florida, 33161, United States
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, 33607, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Phoenix Women's Center (eCast)
College Park, Georgia, 30349, United States
Clinical Trials Select (ecast)
Decatur, Georgia, 30030, United States
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
Decatur, Georgia, 30035, United States
Medical Network for Education and Research
Decatur, Georgia, 30333, United States
Smith & Hackney
Morrow, Georgia, 30260, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291, United States
Clinical Trials Select (ecast)
Silver Spring, Maryland, 20903, United States
Phoenix OB-GYN Associates, LLC
Moorestown, New Jersey, 08057, United States
Central Brooklyn Medical Group (eCast)
Brooklyn, New York, 11205, United States
Rapid Medical Research, Inc.(Elite)
Cleveland, Ohio, 44122, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
SC Clinical Research Center
Columbia, South Carolina, 29201, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Advances in Health Inc.
Houston, Texas, 77030, United States
The Women's Hospital of Texas, Clinical Research Center
Houston, Texas, 77054, United States
Centex Research
Houston, Texas, 77079, United States
Institute for Women's Health
San Antonio, Texas, 78229, United States
Seven Oaks Women's Center
San Antonio, Texas, 78229, 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 L. 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
June 18, 2008
First Posted
June 20, 2008
Study Start
June 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