Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
1 other identifier
interventional
144
1 country
16
Brief Summary
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2006
Shorter than P25 for phase_2
16 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
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 16, 2009
CompletedJuly 8, 2014
July 1, 2014
1 year
April 14, 2009
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata
91 days
Secondary Outcomes (1)
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata
91 days
Study Arms (3)
12.5 mg Proellex
EXPERIMENTALProellex 12.5 mg daily
25 mg Proellex daily
EXPERIMENTALProellex 25 mg
Placebo
PLACEBO COMPARATORPlacebo daily
Interventions
12.5 mg Proellex administered orally daily
25 mg Proellex administered orally daily
Eligibility Criteria
You may qualify if:
- At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
- Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain
You may not qualify if:
- Post-menopausal women, as defined as one or more of the following:
- six months or more (immediately prior to Screening visit) without a menstrual period, or
- prior hysterectomy and/or oophorectomy
- Subjects with documented endometriosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Arizona Wellness Centre for Women
Phoenix, Arizona, 85032, United States
Visions Clinical Research Tuscon
Tuscon, Arizona, 85712, United States
Medical Centre for Clinical Research
San Diego, California, 92108, United States
Women's Health Care, Inc.
San Diego, California, 92123, United States
Downtown Women's Health Care
Denver, Colorado, 80218, United States
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
Miami Research Associates, Women's Health Studies
Miami, Florida, 33143, United States
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, 33607, United States
Caring for Women
Las Vegas, Nevada, 89106, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, 89128, United States
SC Clinical Research Center
Columbia, South Carolina, 29201, United States
Advances in Health Inc.
Houston, Texas, 77030, United States
Obstetrical & Gynecolgical Associates, PA (OGA)
Houston, Texas, 77054, United States
Women's Clinical Research Centre
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andre VanAs, PhD, MD
Repros Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 16, 2009
Study Start
March 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
July 8, 2014
Record last verified: 2014-07