Trial of Mifepristone for Fibroids
Leiomyoma
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring A benign tumor derived from smooth uterine muscle tissue.
Eligibility Criteria
Inclusion Criteria: Gender: Female Age: 18 - premenopausal Have at least moderate symptoms of menorrhagia or pelvic pain/pressure Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is => 2.5cm in size Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale Declined standard treatment options for symptomatic fibroids Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately Willing and able to give informed consent Willing and able to comply with study requirements Exclusion Criteria: Current or planned pregnancy during the study period Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory Currently breast-feeding Untreated abnormal pap smear Presence of conditions other than fibroids contributing to pain and/or bleeding Hemoglobin < 9.0 mg/dl Presence of adnexal masses or tenderness indicating further evaluation or surgery Grade III or IV hydronephrosis by ultrasound Severe, active mental health disorder Active substance abuse or dependence Presence of any contraindication to mifepristone including: Adrenal insufficiency by history Sickle cell disease Active liver disease (liver function tests greater than 1.5 times upper range of normal) Severe, respiratory disease (P02 saturation< 92%) Renal disease (serum creatinine > 1.5 mg/dl) Blood clotting defect. (abnormal PT and PTT) Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus) Current or recent (within the past 3 months) use of the following medications: Oral or systemic corticosteroids Hormones: estrogens, progestins, oral contraceptives Danazol, anticoagulants Herbal or botanical supplements with possible hormonal effects. Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera. Current or planned use during the study of any of the following medications/or products: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampin, St John's Wort, phenytoin, phenobarbital, or carbamazepine
Sites / Locations
- University of Rochester School of Medicine & Dentistry
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Mifepristone
Inert capsule
Mifepristone 5 MG capsule taken once daily by mouth
Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth