Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
NCT ID: NCT00882258
Last Updated: 2014-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2006-03-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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12.5 mg Proellex
Proellex 12.5 mg daily
12.5 mg Proellex
12.5 mg Proellex administered orally daily
25 mg Proellex daily
Proellex 25 mg
25 mg Proellex
25 mg Proellex administered orally daily
Placebo
Placebo daily
Placebo
Administered orally daily
Interventions
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12.5 mg Proellex
12.5 mg Proellex administered orally daily
25 mg Proellex
25 mg Proellex administered orally daily
Placebo
Administered orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain
Exclusion Criteria
1. six months or more (immediately prior to Screening visit) without a menstrual period, or
2. prior hysterectomy and/or oophorectomy
* Subjects with documented endometriosis
18 Years
50 Years
FEMALE
No
Sponsors
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Repros Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andre VanAs, PhD, MD
Role: STUDY_DIRECTOR
Repros Therapeutics Inc.
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Women's Health Research
Phoenix, Arizona, United States
Arizona Wellness Centre for Women
Phoenix, Arizona, United States
Visions Clinical Research Tuscon
Tuscon, Arizona, United States
Medical Centre for Clinical Research
San Diego, California, United States
Women's Health Care, Inc.
San Diego, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Miami Research Associates, Women's Health Studies
Miami, Florida, United States
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, United States
Caring for Women
Las Vegas, Nevada, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, United States
SC Clinical Research Center
Columbia, South Carolina, United States
Advances in Health Inc.
Houston, Texas, United States
Obstetrical & Gynecolgical Associates, PA (OGA)
Houston, Texas, United States
Women's Clinical Research Centre
Seattle, Washington, United States
Countries
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Other Identifiers
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ZPU-003
Identifier Type: -
Identifier Source: org_study_id
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