Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
- Registration Number
- NCT00874302
- Lead Sponsor
- Repros Therapeutics Inc.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- Other inclusion criteria may apply
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 mg Proellex 50 mg Proellex 25 mg Proellex 25 mg Proellex
- Primary Outcome Measures
Name Time Method To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles Four months each cycle
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids Two, 4 month cycles
Trial Locations
- Locations (20)
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
🇺🇸Philadelphia, Pennsylvania, United States
Universidade Federal de São Paulo - UNIFESP
🇧🇷São Paulo, Brazil
Physician Care Clinical Research, LLC
🇺🇸Sarasota, Florida, United States
Hospital dos Servidores Públicos de SP
🇧🇷São Paulo, Brazil
Atlanta Women's Research Inst.
🇺🇸Atlanta, 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
Women's Care Center, PLC Research Memphis Associates
🇺🇸Memphis, Tennessee, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
Vox Femina
🇧🇷Jundiaí, Brazil
Willowbend Health & Wellness Associates
🇺🇸Plano, Texas, United States
Cepeme/Cerfahc
🇧🇷Curitiba, Paraná., Brazil
Brazilmed
🇧🇷São Paulo, Brazil
Hospital Heliópolis
🇧🇷São Paulo, Brazil
Hospital Santa Marcelina
🇧🇷São Paulo, Brazil
Clinical Trials of America
🇺🇸Eugene, Oregon, United States
Soapstone Center for Clinical Research
🇺🇸Decatur, Georgia, United States