- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00702702
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study was terminated by clinical hold.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35235
- Alabama Clinical Therapeutics
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Arizona
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Phoenix, Arizona, United States, 85015
- Women's Health Research
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California
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Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
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Los Angeles, California, United States, 90057
- Impact Clinical Trials
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Los Angeles, California, United States, 90057
- National Institute of Clinical Research
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Los Angeles,, California, United States, 90057
- Impact Clinical Trials
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Colorado
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Denver, Colorado, United States, 80218
- Downtown Women's Health Care
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Florida
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Boynton Beach, Florida, United States, 33472
- Visions Clinical Research
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Leesburg, Florida, United States, 34748
- OB-GYN Associates of Mid-Florida, P.A.
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Miami, Florida, United States, 33161
- Segal Institute for Clinical Research
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Tampa, Florida, United States, 33607
- Insignia Clinical Research (Tampa Bay Women's Center)
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West Palm Beach, Florida, United States, 33409
- Comprehensive Clinical Trials, Llc
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Georgia
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College Park, Georgia, United States, 30349
- Phoenix Women's Center (eCast)
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Decatur, Georgia, United States, 30030
- Clinical Trials Select (eCast)
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Decatur, Georgia, United States, 30035
- Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
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Decatur, Georgia, United States, 30333
- Medical Network for Education and Research
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Morrow, Georgia, United States, 30260
- Smith & Hackney
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Kentucky
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Louisville, Kentucky, United States, 40291
- Bluegrass Clinical Research, Inc.
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Maryland
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Silver Spring, Maryland, United States, 20903
- Clinical Trials Select (eCast)
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New Jersey
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Moorestown, New Jersey, United States, 08057
- Phoenix OB-GYN Associates, LLC
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New York
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Brooklyn, New York, United States, 11205
- Central Brooklyn Medical Group (eCast)
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Ohio
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Cleveland, Ohio, United States, 44122
- Rapid Medical Research, Inc.(Elite)
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Englewood, Ohio, United States, 45322
- HWC Women's Research Center
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South Carolina
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Columbia, South Carolina, United States, 29201
- SC Clinical Research Center
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Medical Research, LLC
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Texas
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Corpus Christi, Texas, United States, 78414
- Advanced Research Associates
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Houston, Texas, United States, 77030
- Advances in Health Inc.
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Houston, Texas, United States, 77054
- The Women's Hospital of Texas, Clinical Research Center
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Houston, Texas, United States, 77079
- Centex Research
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San Antonio, Texas, United States, 78229
- Seven Oaks Women's Center
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San Antonio, Texas, United States, 78229
- Institute for Women's Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
|
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
|
EXPERIMENTAL: B 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
|
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
|
PLACEBO_COMPARATOR: C Placebo
Placebo, 2 capsules daily for 3 months
|
Placebo, 2 capsules daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin vs Placebo
Time Frame: 3 months
|
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZPU-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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