Study Stopped
Study terminated for safety and the FDA put the study on hold for safety.
Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
1 other identifier
interventional
N/A
2 countries
20
Brief Summary
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedJune 27, 2014
June 1, 2014
March 31, 2009
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Four months each cycle
Secondary Outcomes (1)
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Two, 4 month cycles
Study Arms (2)
25 mg
EXPERIMENTAL25 mg Proellex
50 mg
EXPERIMENTAL50 mg Proellex
Interventions
Eligibility Criteria
You may qualify if:
- At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject must have uterine fibroid-associated symptoms during the-screening visit
- Subject has menstrual cycle lasting from 20 to 40 days
You may not qualify if:
- Post-menopausal women or women likely to become post-menopausal during the study
- Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
- Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
- Subject who has had an acute illness within five days of study medication administration
- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
- Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
- Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, 34239, United States
Atlanta Women's Research Inst.
Atlanta, Georgia, 30342, United States
Soapstone Center for Clinical Research
Decatur, Georgia, 30034, United States
York Clinical Consulting
Marrero, Louisiana, 70072, United States
Female Pelvic Medicine
Grand Rapids, Michigan, 49503, 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
Women's Care Center, PLC Research Memphis Associates
Memphis, Tennessee, 38119, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Willowbend Health & Wellness Associates
Plano, Texas, 75093, United States
Cepeme/Cerfahc
Curitiba, Paraná, 80030-220, Brazil
Brazilmed
São Paulo, São Paulo, 01416-000, Brazil
Universidade Federal de São Paulo - UNIFESP
São Paulo, São Paulo, 04015-001, Brazil
Hospital dos Servidores Públicos de SP
São Paulo, São Paulo, 04039-901, Brazil
Hospital Heliópolis
São Paulo, São Paulo, 04230 - 000, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-070, Brazil
Vox Femina
Jundiaí, 13209-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andre van As, MD, PhD
Repros Therapeutics Inc.
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
March 31, 2009
First Posted
April 2, 2009
Last Updated
June 27, 2014
Record last verified: 2014-06