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.
Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Genesis Center for Clinical Research
San Diego, California, United States
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Time frame: Four months each cycle
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Time frame: Two, 4 month cycles
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Physician Care Clinical Research, LLC
Sarasota, Florida, United States
Atlanta Women's Research Inst.
Atlanta, Georgia, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
York Clinical Consulting
Marrero, Louisiana, United States
Female Pelvic Medicine
Grand Rapids, Michigan, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
Clinical Trials of America
Eugene, Oregon, United States
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
Philadelphia, Pennsylvania, United States
...and 10 more locations